CEimpact Podcast

Your Guide to New and Noteworthy Medications

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With numerous new medications launching each year, pharmacists play a vital role in translating complex drug information into practical, patient-centered care. This episode offers a brief overview of select FDA-approved drugs from the past year, highlighting their therapeutic importance, key considerations, and clinical uses. Whether counseling patients or working with healthcare providers, pharmacists need to stay informed about what’s new—and understand its impact on practice.

HOST
Joshua Davis Kinsey, PharmD
VP, Education
CEimpact

GUEST
Joe Strain, PharmD
Professor of Pharmacy Practice
South Dakota State University/Monument Health Rapid City Hospital

Joshua Davis Kinsey and Joe Strain have no relevant financial relationships to disclose. 

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CPE INFORMATION
Learning Objectives
Upon successful completion of this knowledge-based activity, participants should be able to:
1. List unique pharmacological properties for select newly approved medications.
2. Recognize important safety considerations, including adverse effects, interactions, and monitoring parameters, for each featured drug.

0.05 CEU/0.5 Hr
UAN: 0107-0000-25-295-H01-P
Initial release date: 9/29/2025
Expiration date: 9/29/2026
Additional CPE details can be found here.

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Speaker 1:

Hey, CE Impact subscribers, welcome to the Game Changers Clinical Conversations podcast. I'm your host, Josh Kinsey, and as always, I'm excited about our conversation today. With the steady stream of new drug approvals, it's essential for pharmacists to stay informed about what's entering the market. In this episode, we'll review a handful of recent approvals and highlight information to help you support safe, evidence-based care. It's great to have our resident new medication expert, Joe Strain. He's done this now, gosh, I've attended four or five of these with you, I think, now total. I know this has kind of become your thing, which is great. So, Joe Strain, welcome. Thanks for being back with us and for those of our listeners who haven't had a chance to meet you or hear one of your sessions yet, go ahead and take a couple minutes to tell us a little bit about yourself and your practice site and maybe why you are passionate about new meds.

Speaker 2:

Well, thanks for having me, Josh, I appreciate it. Yeah, so I guess I'll tell you about where I'm at now. I've been working for South Dakota State University College of Pharmacy and Allied Health Professions for 22 years now. So I joined the faculty there just a number of years ago, but my practice side has been at Monument Health Rabbit City Hospital for the last 22 years as well. I primarily work with the Internal Medicine Hospitalist Program, but also a few months out of the year we'll work with our Infectious Disease Service as well.

Speaker 2:

My practice is kind of dictated a little bit based on the students I have and what rotation they're, they're kind of assigned to. But I have a couple of great groups to work with there at the hospital that are they value teaching, they value having students around and really value a collaborative practice. So it's it's really a kind of an ideal practice environment for you know my students to see and learn from. As far as new drugs go, it's kind of. Basically, 22 years ago our state association asked me to give a new drug update and as being a new junior faculty, I said, sure, why not? 22 years later it became a. It's still an annual tradition, so I've been back every year, and so it's certainly nice to be able to share this on a kind of another broad platform I guess, if you will, to kind of share some information and just to keep up with new drugs. It's I always say there's nothing.

Speaker 1:

It always feel awkward if someone asks me about a medication I have never heard of it and especially, or if you're watching tv and you see a new drug ad and you're like, oh my goodness, I don't even know what that is, but where have I been? Yeah, so yeah yeah, absolutely.

Speaker 2:

Patients are the same way, right, right, because they get that direct-to-consumer advertising. So they're going to ask you a question. A lot of these drugs I may never even use in my practice, but you still get questions from whether it's family members, friends, you know. Just they see these ads and they want to know about medication. So at least it's always better if you've at least heard of it and have an idea of what it's about.

Speaker 1:

Exactly, if you can at least say it's for X, y, z, you know. So, yeah, absolutely Well. So just to set the stage, well, thanks again. Let me just not forget to say that, thanks again for joining us. We really appreciate it. But as to set the stage, let's just kind of quickly review.

Speaker 1:

Obviously, the FDA has a hand in medication approvals and that's kind of you know the process that we go through. It can be many, many years sometimes for a new drug to make it to market. There are some abbreviated applications and some things can come to market a little bit faster than others, but for the most part it is a multi-year process for something to come on the market. So that's also another reason to highlight them is because you know they've made it so far and it's, you know, even if it's a short audience that it's going to reach, it is for a significant reason. You know like the medication has come out for a significant reason. So so, in that being said, joe, tell us a little bit about how you chose the medications that we're going to talk about today. So it looks like we're going to highlight maybe I don't know a handful, 10 or so. So how did you choose which medications we're going to review today.

Speaker 2:

Yeah. So if you look at kind of the number of approvals on an annual basis over the last 10 years it's been kind of between 45 and 50 on average as far as the number of annual approvals. So you got to kind of narrow that list down. We're not going to talk about 50 medications today but obviously. But when I look at kind of giving these new drug updates in looking obviously, but when I look at kind of giving these new drug updates and looking at the list of drugs that have come out, a number of them are for very specialized conditions, very rare diseases that you're just probably unlikely to come across and there may not be as much direct to consumer advertising as some of those medications.

Speaker 2:

So what I've tried to pick out is drugs that would target kind of a very common condition, so more likely to be have a wider audience as far as what it's going to be marketed to, more likely to come across it, no matter your practice setting. I've also looked at drugs that maybe have a little bit of a unique mechanism and so how is different than the other agents that would currently are on the market for that condition and then also occasionally you'll get a drug that's approved. That is a different dosage form. Let's say, this whole class of medications has been all IV medications and now we have an oral medication available. So I think highlighting that is valuable too, just to know there's an alternative route.

Speaker 1:

Yeah, that's great, that's great. So, like you said, there was, you know, maybe 40, 50 new drugs in the last several months and so, like I mentioned, we've kind of pulled out. Let's see here two, four, six, almost 10 that we're going to try to highlight today and Joe is going to take the lead here, obviously, because he is the expert in this space but basically, just for each one, you're going to kind of tell a little bit about the drug, the indication, you know, like why did it come to market, who is it targeting? You know, where might we see its use being occurring in practice? And then just a little bit about some of the nuances of each medication, right? So if there's something weird that we need to be sure we're counseling on, or if there's some kind of weird dosing thing, or if there's an odd pharmacokinetic, you know, bioavailability or something like that, I'm sure that's what your plans are, is to kind of highlight the nuances and oddities of the different drugs, correct?

Speaker 2:

Absolutely. You know this isn't necessarily going to make you an expert on any of these medications as positive, but it's going to make you familiar, at least have heard of them. And then, if it's something that piques your interest as far as well I could see this impacting my practice, or at least I expect questions about this then you're going to take a deeper dive.

Speaker 1:

Deeper dive Absolutely.

Speaker 2:

We'll at least get you the highlights and give you a feel for where it's at, and then we'll also probably comment on. You know we're going to stick with on-label you know discussion today, but there's a couple of situations where I will mention maybe some studies ongoing for some other things that you might want to keep an eye on down the road.

Speaker 1:

Great, yeah, that's great, that's perfect. That sounds good. Well, I will yield the floor to you and take it away with the first drug and let's go from there.

Speaker 2:

Yeah, so we're going to start off in the ID world. That's obviously a practice area of mine. So we're going to start off with talking about a couple of new antibiotics, and they're both going to be. They're actually both approved for urinary tract infections, and so we know that urinary tract infections are very common, and so our first drug we'll talk about here is Jepotidacin, and that's going to be marketed under the brand name Blue Jepa, and so this one is approved for uncomplicated UTIs in female patients that are at least 12 years of age or older, and it's going to cover all kind of the routine urinary pathogens that you'd expect, like E coli, klebsiella. It also covers Citrobacter, and then Staph saprophyticus and then Enterococcus faecalis, so organisms that you kind of expect to cause UTIs.

Speaker 2:

Now, from a pharmacology standpoint, this is going to work on inhibiting topoisomerase 2 and topoisomerase 4, thus blocking DNA replication, and so if this mechanism sounds familiar, it's because the quinolones work that way, right, but technically it's targeting a different site on those enzymes, so it is acting at a different spot than the quinolones do on that enzyme to inhibit DNA replication. So it is a little bit, it is different and it's not considered a fluoroquinolone. Okay, now, from a warning standpoint, things to watch out for it does cause some QT prolongation. So if you do process, you know, and dispense this, you're going to see some warnings about QT prolongation. Again, probably not a huge deal for most patients, unless they're high risk or if they're on other medications that would cause QT prolongation. Then you might want to raise some awareness about that.

Speaker 2:

The other thing about this drug is that it inhibits acetylcholine esterase and so by increasing the acetylcholine, essentially you are going to potentially increase some muscarinic side effects. And when I think about that I think like GI side effects. And you know, with a lot of antibiotics we have GI side effects and with this one the incidence of diarrhea in the trials was around 16% and it was compared to nitrofurantoin and that was around 3%. So at least compared to nitrofurantoin in the trials we had, it did cause more diarrhea and so GI side effects, and some of that could potentially be attributed to that increased cholinergic activity.

Speaker 1:

Yeah, that makes sense. You mentioned the potential like kind of sort of comparison to fluoroquinolones and I'm completely drawing a blank. But there was a major. What was the major concern with some of the fluoroquinolones not too long ago where I'm drawing a complete?

Speaker 2:

blank. Yeah, well, there's a few different issues. I mean they can cause QT prolongation as well. Then you have the tendon issues with that one Tendon yes, yes, that's what I was thinking of.

Speaker 1:

Yes, so do we see a similarity with this, or is it completely targeted differently and so it's not hitting that?

Speaker 2:

No, the only common side effect or warning that I saw with this in the quinolones was the QT prolongation. It didn't have the concern about the aortic aneurysms and that was another kind of as well, I was thinking of the tendon one.

Speaker 1:

Now, I thought it was something to do with a muscle or something, and so, yeah, that is exactly what I was thinking, okay.

Speaker 2:

None of that was reported in the trials anyway, so hopefully that's not the case. But you know, again, some of that stuff does we always kind of keep an eye on things and see how things evolve. But so far so good on that front.

Speaker 1:

Okay, sounds good, go ahead. I interrupted you. No, you're good.

Speaker 2:

Just please feel free to ask. I can try to clarify the best I can here. I just want to comment a little bit on efficacy with this medication. There was a couple of phase three trials done. Again they were studying it against nitrofurantoin. Both drugs were used for five days of therapy and one of the trials basically showed it to be non-inferior to nitrofurantoin. So just as good. But the other trial actually did show a little bit better outcomes in regard to symptom resolution and microbiologic cure with the Jepo-Tadasein than nitrofurantoin. So it at least works as well as nitrofurantoin and one of the trials actually worked a little bit better, okay that's good.

Speaker 2:

Yeah, and so just to kind of highlight the dosing of this, it's going to be 1500 milligrams twice a day. It's going to come as 750 milligram tablets, so you're going to take two tablets twice a day and then it's indicated for five days. That's how the studies were done. We still avoid it in severe like renal impairment, like creatinine clearance less than 30. That's probably kind of the one area where we tend not to want to use it in that population. But overall, again, it's another agent to add to the market.

Speaker 2:

Now, if you think about it, do we have a lot of agents for uncomplicated UTIs that are pretty cheap? Yeah, we do. The question here is what's this going to cost? This is expected to be out second half of 2025, which is where we're at right now, but we have not seen it formally released yet, so I don't have a specific price for you on this one as of yet. Obviously, that would be a potential barrier when you're talking about an agent for uncomplicated UTIs, when you're comparing it to things or other medications that have been around for years that are generic and very inexpensive.

Speaker 1:

Right, yeah, yeah, I think that was going to be. My question is is there something that really stands out that makes this shine differently, like would there be a contraindication on a cheaper medication, or something that makes this one be like, okay, yeah, this is the new gold standard or anything, or is it really just?

Speaker 2:

I don't think it'll be prime time for UTIs, but the one area where you want to keep an eye out. It's currently under review at the FDA for Neisseria gonorrhea as an oral option, and so the FDA is reviewing that data. I think they have a review date of December of this year. So just you know, just here, in a few months the decision will be made on that and I'm not going to go into great detail on the data, but some of the preliminary stuff. I think there's optimism that this may eventually play a role for that condition and there's really limited oral options in that regard, so that I think this is one where I wanted to mention stay tuned for more data coming with this medication, because that does have potential in that area.

Speaker 1:

Yeah, okay, great, that's great, okay. Well, let's move on to the next one then.

Speaker 2:

Yeah, so the next one's also another agent approved for uncomplicated urinary tract infections, and this is Sulopen plus Probenicid, so it's a combination tablet, or Linva is going to be the brand name, but again, if it sounds like a carbapenem, it's because it's very similar to the carbapenems. It's actually going to be termed a thiopenem, but it's still a penem. They've just substituted a sulfur molecule in one of the rings there, but it's being touted as being very similar to the carbapenems as far as kind of how it's structured, I guess, if you will. But a couple things to note with this. So the thought is well, okay, now we have an oral carbapenem, right, and so is this going to be used as kind of a step-down therapy.

Speaker 2:

But if you look at the labeling, it's only approved for uncomplicated UTIs caused by E coli, klebsiella or Proteus in adult women with limited or no alternative oral options. So it's again pretty small market where you're just you're stuck with. You don't have any other options for these specific bacteria. It's interesting in the labeling they do specifically note that it is not indicated for complicated UTIs or a step-down therapy from IV treatment for those infections or for complicated intra-abdominal infections or a step-down therapy. And the reason why is because there's specific data out there that did not meet the non-inferiority criteria compared to the IV or dependent in those studies. So it's it's interesting when you see a drug that gets you need to see what it's labeled for. You don't always see what it's not used for.

Speaker 1:

Yeah, that's interesting.

Speaker 2:

Yeah, so it's just not ready for kind of that role yet, at least based on the current data we have Now. We'll see what happens with research and development down the road, but I think that was the initial thought. But again, just want people to be aware that the current data that's out there did not support it in that role. Interesting, okay, they've combined it with probenicid and we know probenicid will inhibit renal tubular transport, and so that's intended here to try to increase the levels of the sulopenem to make them therapeutic, and so that's why they had to combine it with probenicid to achieve those therapeutic levels. A couple things to note when you take this one. It has to be given with a high fat meal to increase absorption. That is going to be critical, otherwise you're not going to get enough absorbed, and so that's going to be something to note.

Speaker 2:

From a side effect warning standpoint. There's really not a lot new here. I mean there's some things that go along with Probenicid. We don't use Probenicid a whole lot anymore and so just thinking about drug interactions with that, because of all the things that would inhibit from a renal tubular transport system, if you did come across this medication down the road you would run into some drug interactions with the probenicid part of it. But the sulopenem is very similar to our other beta-lactams and so not a lot new there for warnings, if you will. But you know another oral antibiotic. So what do you expect for side effects? You know GI things. You know diarrhea was more common in the clinical trials with the sulopendium compared to the other antibiotics that were studied against, and so that's something again to be expected. I guess it's about 10% of patients experience that Okay.

Speaker 2:

Okay, from an efficacy standpoint, just to highlight a couple of trials studied it against amoxicillin and clavulanate. So Augmentin looked at both of them for five days, basically showed it was non-inferior to Augmentin. Again, most of these patients just had E coli UTIs. Again, these were uncomplicated UTIs. They also studied it against ciprofloxacin. They used the cipro at a low dose, 250 BID, for three days In the overall population. They showed it to be non-inferior. There was a couple of caveats of different arms. They looked at where. So there's a little more involved with that trial. If you want to take a deeper dive into that, I'd encourage you to do that. But overall, again, it works for uncomplicated UTIs. Essentially, dosing is fairly simple. We mentioned taking it with food, but it's just one tab twice a day.

Speaker 2:

You won't see this used widespread and I don't think a lot of people are going to encounter this. If you go to the company website on this one, it's actually going to be exclusively available through Alto Pharmacy, which has limited sites across the country. There's like four in California, three in Texas and a couple are scattered throughout the nation on that, but that's where it's going to be distributed through, so I think it's going to be pretty restricted. It's also very expensive. The AWP on a five-day course is about $3,500. So it's very expensive. But I think it's good to bring up just so people are aware that if you hear of an oral carbapenem out there, this is technically a thiopenem antibiotic but very similar to the carbapenems and so it is out there and we'll see where this evolves down the road if there ever is more data out there to use as a step downdown therapy. But currently the data would not support that.

Speaker 1:

Yeah, I think it's important to highlight that because if you were to just hear, oh, there's an oral phenome, you know, you might think, oh, I can do the step-down, or I can you know this would be an easy way to send someone home with.

Speaker 2:

So yeah, great points, and we'll see how our ID experts utilize this. I think that's where it'll probably be. The main focus, though, is your ID experts that are dealing with highly resistant bacteria, and they'll see how they utilize it and then continue to research.

Speaker 1:

It really Sure, sure, okay, all right. So that covers some infectious disease and UTI. So let's jump into the next one. I think we're going to get into some medication for schizophrenia, right?

Speaker 2:

Yeah, so we got a new medication out for schizophrenia Again, schizophrenia, very common condition. The drug that is approved here is Xanomelaine and so, but it's going to be combined with Tropsium and marketed under the name Cobenfi. And it's interesting because this drug actually you talk about drugs in development for a while there was actually I came across a trial that actually demonstrated efficacy of this medication. That was published back in 2008. Wow, yeah, so quite a while ago. So it's been in the pipeline for a while.

Speaker 2:

But the issue was the GI side effects. And so why is there so much GI side effects with this medication? And it's because this works different than our other typical schizophrenia medications. Right, we typically focus on medications that block dopamine receptors, specifically dopamine 2 receptors. That's kind of our backbone of schizophrenia treatments. But this one actually works as a muscarinic agonist. So it acts on a wide variety of muscarinic receptors, but specifically looking at M1 and M4, that tend to be decreased in schizophrenia. So there's been some research done there, and so the thought is, by stimulating these receptors we can help treat the symptoms of schizophrenia. So it's kind of fascinating that we have a completely different mechanism here to treat this disease.

Speaker 2:

State Now again. So the side effects were always the issue with this. Because you have muscarinic stimulation, you get a lot of that in the GI tract. It makes you get a lot of GI side effects. So what they did was combine it with tropsium, which is a peripheral muscarinic antagonist, to counteract all those gi side effects. Tropsium won't cross the blood-brain barrier, so won't impact the effects you'd be seeing on the muscular receptors in the brain. So interesting.

Speaker 1:

That's pretty. That's pretty innovative and novel. I like how they were thinking on that. That's interesting.

Speaker 2:

Yeah, okay, and so from a kinetic standpoint, the really only thing you have to watch for is it doesn't need to be given with food because the tropsium absorption is or no. I'm sorry. It needs to be given on empty stomach because the tropsium is decreased with food. So you have to give this one an empty stomach and it's because of the tropsium component being decreased with food. So just watch out for that.

Speaker 2:

The contraindications and warnings really stem around the muscarinic effects and the antagonistic effects you might get with the tropsium. So urinary retention, decreased gastric motility, increased heart rate. Those are the types of things you just want to watch out for. So kind of think, anti-muscarinic or anti-cholinergic, if you will. With atropium, part of that, same thing with the side effects. It's basically GI side effects nausea, dyspepsia, constipation, vomiting those types of things we're seeing more commonly than the placebo arm. But we do avoid the dopamine side effects, such as all the extrapyramidal symptoms. We don't see the weight gain with this either. So it just has a very different side effect profile compared to our other agents we use for schizophrenia.

Speaker 1:

Oh, did they see a lot of the GI side effects still occurring when they made it the combo? So it's still there. It doesn't completely get rid of it.

Speaker 2:

Exactly. That's a great point. So, while it reduced it to the point where at least it's tolerable, yeah, most patients could tolerate it, but they're still there and you saw like 15 to 20% incidence rates Again a lot of them. You know how severe is that. It wasn't as severe as it was because you know, prior to that they didn't even they realized you couldn't even go forward with it because of all the side effects by itself. So it does help, but it doesn't eliminate them Got it. Okay.

Speaker 1:

So, again, key counseling point there would be to take it on an empty stomach, because you want the tropizium to be the one that's working for sure as well, so that you're not having terrible side effects.

Speaker 2:

Exactly. So take this one hour before or two hours after meals Got it Okay. As far as where it was studied, it was just studied against placebo. It did show it had a positive impact on both the positive and negative symptoms that you would see with schizophrenia. So, but again, no direct head-to-head trials that I've seen published comparing it to kind of some of our more traditional agents that we've always used.

Speaker 1:

Okay. So as far as place in therapy, is this going to be just an alternative for those that don't like some of the other side effect profiles?

Speaker 2:

Exactly. I think it's going to be marketed that way. As far as if you're looking for a totally different mechanism here, avoid some of those side effects, some of those EPS concerns that some people have or maybe have experienced, then this does become an option.

Speaker 1:

I think is where we're going to see this, and so that sometimes is a rate limiting factor for some people to take the medications. You know they don't want the weight gain, you know that kind of thing. So yeah, ok.

Speaker 2:

Absolutely, and some people really struggle with some of that. So it's, and it can be a reason to lead to noncompliance with some of the medication. Exactly, and yeah, so that's it's. It's a good it's. I think this is a nice addition to the market. We'll just see how how it plays out in practice as far as how our providers and patients deem its effectiveness and and and side effect profile. If it's tolerated, we'll see how that goes. It is a titrated medication as far as when you first start, there's going to be a starter pack where you start with a lower dose and the idea there, I think again, is those GI side effects can they tolerate it? And then your titration is kind of based on how much can you tolerate from a GI standpoint. And if you can, if you're not having issues, then they actually will step up in therapy and go up on the dose. But if not, you can back off a little bit too and there's a lower dose that they can be maintained on. Got it Okay, makes sense.

Speaker 1:

Yeah.

Speaker 2:

It's expensive. Like any other new drugs, these are a little over $2,000 for a 30-day supply. Unfortunately, a lot of our some of our other psychiatric medications are expensive as well. This is right up there, though. There's a copay card available, though, and there's. If you look at the company website, it says you can pay as little as zero if you have, you know, the right type of insurance and go pay a car.

Speaker 2:

So again, you know hopefully practitioners in that field. If this is in your area, you'll be navigating that a little bit to figure out if you can get it paid for.

Speaker 1:

Okay, that's great. So another, the next one. Looks like we're going to turn to gain some traction recently, or at least some attention, as being a treatment for pain, and one of the first in several years that is, a non-opioid treatment for pain, right.

Speaker 2:

Yeah, and I agree with you. I think this is the one I've probably had the most questions about from providers, and some of that's probably due to some marketing that's been going on too. But with suzetrogene is the name of the drug, I'm going to be marked under Jernovix, and so this is a medication that's approved for moderate to severe acute pain. So, again, a very common thing you'd encounter, right? We have a lot of different medications we'll utilize for acute pain.

Speaker 2:

A lot of them are opioids, but this is a non-opioid. This is actually a sodium channel inhibitor, and if you think of other sodium channel inhibitors that might be used for pain, even lidocaine comes to mind, right, but lidocaine is very non-selective as far as it hits a lot of different sodium channels, and this is actually specific for the sodium 1.8 channel. So it inhibits that specific sodium channel which is just expressed in the peripheral sensory neurons, and so it'll block those action potentials in the periphery that will transmit those pain signals, and so that's how it would have its impact. Again, it's a non-opioid. There's no addiction potential that's been identified with this medication, so it's fairly clean from that standpoint, which is always a nice certainly welcomed.

Speaker 1:

So we don't see any kind of controlled status or control classification for this.

Speaker 2:

Okay, Nope, it is not labeled as a control substance. That's correct. Okay, as far as how, when you take this medication, food will delay the initial onset, so it's it's in decreasing those initial concentrations. So this is interesting and that you'll see that the first dose needs to be given without food and then once you get those levels up with that initial loading dose, then after that you can take it with or without food. It'll help, it'll maintain. But that and the idea there is to get that onset on a little bit quicker. It's thought that looking at the kinetic data and the onset, does it work as quick as an opioid? There's some question about that in some of that data. But just remember, taking it without food will help with that onset of action. The T-max is about three hours as far as time to max concentration with this medication. So that'll be an important thing to kind of remember if you're going to be using it, because from a side effect standpoint it's actually very well tolerated.

Speaker 2:

The side effects were very limited. They looked at you know things, common things like nausea and vomiting, you know which is you know common post-surgery, and that's really where they studied. It was post-surgery. They had a placebo arm, they had a hydrocodone and acetaminophen arm and then they had this cesatrogen arm and they actually showed that nausea and vomiting incidence is actually even lower than placebo and lower than hydrochloric and acetaminophen too. But as you kind of expect that, but it was, yeah, so it was actually fairly well tolerated, even from a GI standpoint. So that's certainly welcome too From an efficacy standpoint. I think that's where the question comes in is how well is it going to work? The two trials where they you know that you'll see in the labeling were for bunionectomies, so post-surgery for that, and then abdominoplasty, so kind of like you know it turned as a kind of a you know two surgeries that they'll look at these pain medications in.

Speaker 1:

What was the first one? You said Joe.

Speaker 2:

A bunionectomy, so a bunion surgery.

Speaker 1:

Okay, that's what I thought you said. I was like wait, do you mean like the removal of a bunion off your foot? Okay, it sounds very specific why they would choose that.

Speaker 2:

It is, and I've seen other pain trials that have specifically looked at these two surgeries, for whatever reason, I don't know.

Speaker 1:

Interesting Okay.

Speaker 2:

Yep. And so they looked at three different arms that placebo arm, they had hydrocodone and acetaminophen and with that dose they looked at a 5-325 dose every six hours and so again kind of a fairly, you know mild dose of that right I would say, um, and then they can then add this is estrogen arm and then they could use the ibuprofen for breakthrough basically, and if you look at the pain scores that they looked at over a 48-hour period, it was superior to placebo as far as pain reduction and basically kind of it was kind of an active comparator on with the hydrocodone, but basically fairly similar is what they kind of determined. It wasn't deemed superior to hydrocodone by any means, but the overall numbers, if you look at the timeframe and how the pain scores line up, it was fairly similar to that. But again, keep in mind, the dose of the hydrocodone, acetaminophen is 525 every six, which again you know it's just got to know what it was compared to, I guess, sure, sure. So it'd be interesting to see how this is utilized.

Speaker 2:

As far as the dosing goes, it's oral only and so again they were looking at post-surgery patients. So you're given 100 milligrams up front and then 50 milligrams every 12 hours after that. Again, that first dose. It's going to be two tablets because it's going to come as 50 milligram tablets. So you take two of them for that first dose and then go down to one tab every 12 hours after that. But again, keep in mind that first dose needs to be given without food for trying to get that onset on a little bit quicker. Try to get that onset on a little, you know, a little bit quicker. It's fairly spendy. Awp is around $19 a tablet. So, and the data that led to the approval there was really no data beyond 14 days of use. So we'll see. Just keep. It's meant for kind of these shorter acute pain syndromes.

Speaker 1:

Yeah, okay, do we think that it's well? I guess you just kind of answered that question. I was going to say is this an alternative for? But I guess it could be, like post-surgery, an alternative for those patients who do have addictive tendencies and want to stay away from an opioid, like I mean, do you think it's going to be a a great option for them? Like, are we going to see it used in that fashion?

Speaker 2:

I think that's where it's going to be targeted. Now the question is will it be perceived to work as well and will it work as well? I don't have any direct experience with that, and so I think time will tell. With that, right, your surgeons that are going to be prescribing this and your patients are going to be given feedback, but I think it's a very reasonable approach to take. If you're trying to avoid opioids, which ideally yeah, if you had a pain medication that worked, you could avoid opioids. That'd be fantastic, right.

Speaker 2:

But it's just a matter of is it going to work as effectively, or will it be added on as kind of this multimodal post-op pain approach? We're starting to do a lot of that right, and a lot of places are fully implemented these multimodal post-op pain approaches with using some of our other agents, implemented these multimodal pain post-op pain approaches with using some of our other agents, and so will it be incorporated into that as well. So, again, I think it'll be interesting to see how this plays out over time. This is also a drug class where I think we're going to see more specific inhibitors of these specific sodium channels researched down the road. Now we'll see how many make it to market. But the thought here in reading some of the literature is that there could be others down the road with similar mechanisms, and we'll see if there's a clinical difference in them too. That's very preliminary.

Speaker 1:

Okay, so the trend could be that more drugs in a similar class working on a similar pathway. Then Okay, and sometimes we'll see that right.

Speaker 2:

You get the first one to the market and then you'll see others come. But we'll see Again. I don't have a lot of hard data to support that yet, but in reading some of the literature I think that it's kind of suggested that that's potential to happen.

Speaker 1:

Okay, all right, very interesting. Like I said, I know that's been one that's been heavily discussed and touted as being, not to play on words, but a game changer, you know, and so I'm anxious to see, kind of, how that plays out. I'm hopeful, I hope that that is an option and that we can, you know, get more medications in a similar class to get away from using some of the opioids. So yeah, that's great.

Speaker 2:

That would be a deal in everyone's mind and I know it's out there. They're marketing it. I was down in our hospital's office the other day and they were asking about it and there were some materials down there. So it is being marketed. So if you haven't heard about it already, you probably will soon.

Speaker 1:

You will. Okay, all right, sounds great, all right. So let's move into our next one. And I lost my place, joe, so tell me what we? I scrolled my screen and I lost it, so tell me what's up next.

Speaker 2:

No worries.

Speaker 2:

So Berdazimer is the next drug that we'll talk about, and I think you pronounced the brand name Zolzuveme but it starts with a Z, but this is going to be a topical medication and this is approved for molluscum contagiosa in ages of one year and older.

Speaker 2:

So this is primarily a skin condition you'll see in pediatric patients and it's basically it's a contagious condition. It's caused by the pox virus, but usually it's pretty benign and most patients get over it on their own. It basically causes these small raised dimples with a little pit in the center that can kind of appear anywhere on the body, but they can itch and if a child starts itching it, you know, too aggressively, you know then you can get some breakdown of the skin and then you know that could potentially, you know, an infection on top of it and that would be kind of worst case scenario. But a lot of them will go away on their own. But there is a certain percentage in reading about this. About 30% are reported to still have bumps, persist at like 18 months and then depend on your immune system and can even go longer than that. So some patients may get treated for this condition, but certainly not necessarily everybody.

Speaker 1:

So definitely not one we're going to see used a lot in practice probably.

Speaker 2:

I don't think so. I think it's just good to be aware that it's out there. It actually works by releasing nitric oxide. That it's out there, it actually works by releasing nitric oxide, they'll say in the labeling. The mechanism is unknown as far as exactly how this drug works for the pox virus, but in vitro there's data that it shows it blocks the replication of the pox virus, and so that's how it got the and it's a topical product right.

Speaker 2:

It is a topical product so you don't really have to worry about any kinetic issues with this one. There's minimal systemic absorption there. The side effects you would see are mostly local. They report mild pain as probably being the most common side effect with the application. A little erythema, a little itching. I mean the condition itself can cause itching, but it appears there's a little more itching even on top of this because, compared to placebo, about 4% reports a mild itching with the application versus about 1% reports a mild itching with the application versus about 1% placebo. So perhaps there's just some localized effects.

Speaker 2:

Again, most patients continued it and didn't have to stop it. From an efficacy standpoint, just briefly, it was studied against placebo. It can be used for up to 12 weeks is how it was studied, and they were looking at complete clearance rates of all the lesions and there was about a 10 to 13% difference in complete clearance compared to placebo of all the lesions. There was some secondary outcomes looked at as far as like, even though it wasn't a complete clearance, did patients perceive a meaningful clearance and, in a fair percentage, actually perceived a meaningful clearance of those as well. So we'll see how much how efficacious it is once it gets into practice you know, I think, your providers and your patients again we'll see how well it works.

Speaker 2:

But it's simple. Though it's once a day, to each lesion for 12 weeks. I mean that's probably the most complicated part of it. You got to be persistent with it and do it on a daily basis, but it is once a day, so it's not like it's something that has to be done. You know multiple, but it is once a day, so it's not like it's something has to be done. You know multiple times a day. If you do dispense this, it comes in two different tubes. There's the active drug in one tube and there's a hydrogel in another tube, and so there'll be a card that comes with the product that will indicate how much of each tube to put on the card, to mix with your finger and then apply it to each lesion what yeah, that's why okay's a little different.

Speaker 2:

So you just want to be aware. If it shows up, you're just going to have to probably roll out the instructions a little bit and go through it with the patient, because there's a process for doing that. And then after you apply it, it needs to dry for 10 minutes and then avoid washing that area for at least an hour after the application.

Speaker 1:

Interesting. So you said like a card, and you scored a little bit of each and then mix it up with your finger.

Speaker 2:

Yep, I haven't laid my hands on one, but it's supposedly. There's two lines on the card that'll tell you put this much gel on or cover the line with this active product and cover the line with the gel right next to each other Stir it together with your finger, make sure it's good and mixed up. I think they say to count to 20 is what is in the instructions, so 20 seconds, I guess, to make sure before you apply it Interesting?

Speaker 1:

Yeah, that is definitely. That's a first. I don't think I've heard of anything like that before.

Speaker 2:

Yeah, and it's expensive too. It's a 31 gram tube and the AWP is $2,300 for it. So again, there's a patient assistance program, but it's on the website. It's going to be available through. You know community pharmacies. They've listed you know some common, you know community pharmacies as carrying this or that will be carrying it.

Speaker 1:

Okay, so even more important at that price, to make sure that we counsel properly on using that card and getting the exact amount so that they're not overusing it Exactly. So, yeah, for sure, yeah, you can't be wasting this one, absolutely. Yeah, okay, yeah, okay. Anything else on that one?

Speaker 2:

No, I think we're good to move on.

Speaker 1:

Okay, looks like the next one is anemia.

Speaker 2:

Yeah, so our next product is known as Vedatostat Vafcio, I think, is how they're going to pronounce the brand name and this is going to be used to treat anemia in patients that have been on dialysis for at least three months your chronic kidney disease patients and this is actually the second drug in this class to be approved by the FDA. Diprotestat was approved back in I think it was 2023. So I actually talked about a very similar drug a few years ago, but they've actually pulled Duprutastat off the market and I just don't think it ever really took off. And so the question, when this one got approved is okay, well, we have another one that we're approving it, but is this going to take off or is it going to kind of not you know kind of struggle a little bit like the other one? So we'll see.

Speaker 2:

The mechanism is very similar. They basically work by increasing erythropoietin production, so it's an alternative way of increasing erythropoietin as opposed to just giving erythropoietin at dialysis sessions, and so it basically blocks the metabolism of some of these transcription factors. Essentially is what happens, and so, and that process is downregulated in end-stage renal disease, and so we're basically kind of you'll see it, you'll read about it causing like the pseudo hypoxic condition. So it doesn't really cause hypoxia, but it makes the body kind of think it is, and so then it ups the transcription factors and to produce more erythropoietin.

Speaker 1:

Interesting.

Speaker 2:

Yeah. So it's kind of an interesting mechanism, but it's you know. So why wouldn't you just give erythropoietin? You could say yeah, you could do that. This is basically an oral option.

Speaker 1:

Okay, that was going to be. My question was what's its hook? Because it just seems like there's the mainstay of just giving directly erythropoietin. So what is this one doing? Okay, dr.

Speaker 2:

It's just a little bit of a different mechanism to increase erythropoietin, but you're right, it's just the oral option. Essentially is what it is. It's interesting that you know in the United States these have only been approved in dialysis patients, but in Japan there's actually three of these products that are approved in dialysis and, reportedly, in non-dialysis patients, so I could maybe understand the role there a little more. But the safety data that the FDA has reviewed for the non-dialysis patients, they did not deem it to be meeting some of the safety outcomes that they wanted, mainly from a cardiovascular standpoint.

Speaker 2:

We know, like with erythropoietin, you know we keep an eye on hemoglobins and making sure we're increasing them too much or too fast. Potential concern for, you know, things like MI, stroke, thromboembolism. Well, this is very similar. We don't want it to go up too much, we don't want to go up too fast, and so they've really required a lot of the data and scrutinize the data to make sure it's going to be safe before they'd approve it. And so they have not approved it in those non-dialysis patients as of yet.

Speaker 1:

So that was. My next question was why is it just for dialysis?

Speaker 2:

Okay, yeah, it's just the safety signals in some of the trials they are concerned about because in the dialysis patients this product in particular studied against Darbopuitin and the safety signals were all very similar. There wasn't a real difference in a lot of the outcomes as far as the safety measures. So that's why they've deemed it to be as safe as darbopoietin anyway in the trials and that's what led to the approval here. Okay, there is one drug interaction I want to note with this because it's oral. If you give it with calcium or savelimer or iron for that matter, it will decrease the absorption. So you have to separate it from those drugs. And I bring that up because your dialysis patients are generally on at least one of these, right? Um, the calcium and savella are commonly used as a phosphate binder in these end stage renal disease patients on dialysis. So that's, that's a drug interaction if you did opt to use this you'd want to be aware of, because that's something that would commonly be encountered. So we just have to separate it out, okay.

Speaker 1:

And then pricing, are we? Yeah, it's expensive.

Speaker 2:

It's 300 milligram tablets, which is where you start. The AWP is $1,500 a month, so it's a once a day tablet, so it's not that complicated to take. And again, I don't know how the payment's going to work with this, with the dialysis payments and all that. I know when the protostat came out, they were talking about bundling it with that, but I don't know how that actually played out. Obviously it didn't take off because it's not on the market anymore, but I don't know.

Speaker 2:

I have not seen reports on how this the payment will go for this. But if you work in the dialysis area, this is something to investigate and be aware of if your providers are going to be asking you about it. And again, is there an advantage of using an oral tablet once a day as opposed to just getting the erythropoietin at dialysis sessions? I don't really know that. I mean, you kind of assure compliance by giving the erythropoietin at dialysis as long as they show up for dialysis, right, but with the tablet form, you're going to be relying on them to take it once a day at home, but with the tablet form, you're going to be relying on them to take it once a day at home.

Speaker 1:

Okay, all right, then it looks like our final one is going to touch on eye, so dry eye disease.

Speaker 2:

Yeah, so we got a new eye dropout called Acoltramon Triptir is the brand name of this one, and so, yeah, approved for dry eye disease, which is actually fairly common. I looked up some stats on this this and they said estimate about 38 million people in the United States are impacted.

Speaker 1:

Yeah, we did a podcast on this recently and I was shocked by the number of patients that have dry disease.

Speaker 2:

So yeah, yeah, very common, yeah, and there's a number of agents out there used for eye drops. I talked to a couple of my optometrist colleagues that I know fairly well and asked them about it, and they hadn't really heard of it being used as of yet. But they commented on the other products that they like to use. You know cyclosporine. There's a couple of other ones that you know block tear evaporation and impact inflammation. There's also varenicline nasal spray. That's a cholinergic agent that's actually used to increase tear production. I don't know if that's being used a whole lot either, but it seems like the patients that I see come into the hospital tend to be on cyclosporine drops fairly frequently. It's one of the more popular ones that's utilized.

Speaker 2:

But I bring this one up because pharmacologically it's unique compared to the other products that are out there. And how this works is it serves as an agonist of transient receptor potential melastatin 8 thermoreceptors. So I don't know if anyone will be able to memorize that specifically in that field, but it's a mouthful. But essentially what it's doing is it's activating the trigeminal nerve signaling, which will increase basal tear production. Okay, so it's through a different mechanism and so it does that provide an advantage? I don't know, it's through a different mechanism, and so does that provide an advantage? I don't know. It supposedly provides a cooling sensation to the eye, and so I don't know if that'll be perceived as beneficial or not.

Speaker 1:

I was going to say is that supposed to be a plus? I feel like that would be annoying.

Speaker 2:

It might be. In fact, in the reports, the adverse reactions, 50% of patients reported some sort of pain with installation, but less than 1% actually stopped the drug because of any burning or stinging. So I don't know that it's. There must be some sort of mild pain, but not enough to stop the drug, at least in the trials. Okay, you do have to remove contact lenses before applying. So if you you know contacts are pretty common, again with dries, they may be avoiding them, but if you want to use your contacts you have to remove them, apply the drop, but then 15 minutes later you can reinsert the contacts if you want to use them. Got it. Okay. A little counseling point there.

Speaker 2:

It did increase tear production against placebo, but the primary outcome was looking at 14 days, and that's where a lot of these drugs will be. Say that will work as early as 14 days. This drug, actually, when you look at the marketing labeling of it, it says it works as early as day one, and so I could see it being marketed that way that maybe it would work a little bit quicker than some of the other agents. Again, no head-to-head trial with other agents, so it's hard to make that claim directly comparing to something else. But you are going to see the marketing and saying it works as early as day one.

Speaker 1:

Okay, okay, all right, anything else on that one, so fairly simple, the cost.

Speaker 2:

I was gonna mention just cost before we wrap up, because a lot of these agents in this class are expensive. Talking to one of our optometrists, yeah, a lot of them are over $600 a month. This one's AWP is around a thousand. So again, it can be pretty spendy, but it's one drop twice a day, so fairly easy to use. It comes as these individual single dose vials that was gonna be.

Speaker 1:

My next question is is it? Is it a multi or a single?

Speaker 2:

okay, single so it'll be pretty simple. There'll be cartons with multiple vials, pouches with multiple vials in the pouch.

Speaker 1:

I guess is how it's going to be, so okay okay, all right, well, that's, that's great and looks like that's all we had time for and, just as always, I feel like I just sit here like a sponge and learn so much. I don't know how many of these I'll ever see and hear about officially, but it's just interesting to hear the research that's going on and the new innovative pathways that they're finding to treat things. So yeah, very, very interesting pathways that they're finding to treat things. So yeah, very, very interesting. So, joe, as I always like to do at the end of an episode is ask what the game changer is. So you know what? Again, why is it important that we stay up to date? Just reiterate that rephrase the importance of pharmacists staying up to date on new medications. So it's kind of restating the obvious, but I'll let you do it.

Speaker 2:

I think, just so you can be a resource for not only your patients but your providers, your colleagues and your friends, they're going to ask you about all these things, and so just to have good conversations about where some of these new medications might fit, because there is a couple that you might see a niche for, right, I mean a non-opioid pain medication. If it truly does have a positive impact on pain, that would be a great potential agent to be aware of, even the xenomelan from a schizophrenia standpoint, having a different side effect profile just to be able to answer a question for a patient that's struggling, maybe, with some side effects. Have an alternative option. An alternative option, absolutely and again, with all the direct-to-consumer advertising. It's interesting.

Speaker 2:

That's interesting that you know a lot of our patients will watch commercials, right, and so they'll ask questions and, like you talked about that, and it's kind of fascinating that there's only two countries in the world that allow direct-to-consumer drug advertising, right, I mean, I think a lot of people are maybe aware of that, but some people might not be. Us in New Zealand, I guess, are the only two, but a lot of patients get some information that way, but they're still going to rely on pharmacists as the experts, and so it's good to stay up on these things so we can have a good conversation with them about these, and I think you brought up another great point and that other providers may be asking our opinion and our expertise as well.

Speaker 1:

And let's face it, we are the medication experts, so we should be up to date and be able to collaborate and answer questions and offer again solutions, alternatives, if they come to us with a problem patient of you know I'm having XYZ issues and I need another alternative. So it's good to kind of know what's out there and, just like you said, at least wetting the appetite and we can dig deeper if it's something that we come across. But at least we've now been made aware of them and heard of them. So, yeah, super great. Well, joe, thanks again. It's always a pleasure. I, like I said, always learn so much and just really appreciate you giving us your time. So thank you.

Speaker 2:

Yeah, thank you for having me today?

Speaker 1:

Absolutely. If you're a CE Plan subscriber, be sure to claim your CE credit for this episode of Game Changers by logging in at ceimpactcom and, as always, have a great week and keep learning. I can't wait to dig into another game-changing topic with you all next week.