CEimpact Podcast

New Prescription Option for Fibromyalgia Treatment

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Patients with fibromyalgia have waited more than a decade for a new therapeutic option, and a recent regulatory approval signals a shift for these patients. This episode reviews the clinical trial data, mechanism of action, dosing considerations, and pharmacist‑relevant monitoring for the newly approved sublingual formulation of cyclobenzaprine HCl. You will gain practical insights to inform patient education, therapy optimization, and interdisciplinary collaboration in fibromyalgia care.

HOST
Rachel Maynard, PharmD
GameChangers Podcast Host and Clinical Editor, CEimpact
Lead Editor, Pyrls

GUEST
Amanda (Mandy) Mullins, PharmD, BCPS
Clinical Pharmacist Practitioner
Veterans Affairs

PRACTICE RESOURCE
Purchase this course to receive the exclusive downloadable practice resource handout to use as a reference guide to the podcast

CPE REDEMPTION
This course is accredited for continuing pharmacy education! Click the link below that applies to you to take the exam and evaluation:


CPE INFORMATION
Learning Objectives
Upon successful completion of this knowledge-based activity, participants should be able to:
1. Describe the mechanism of action and key clinical trial outcomes associated with the newly approved prescription medication for fibromyalgia.
2. Identify pharmacist responsibilities for dosing, monitoring adverse effects, and patient counseling when supporting the use of this new fibromyalgia therapy.

Rachel Maynard and Amanda (Mandy) Mullins have no relevant financial relationships with ineligible companies to disclose. 

0.05 CEU/0.5 Hr
UAN: 0107-0000-25-371-H01-P
Initial release date: 12/15/2025
Expiration date: 12/15/2026
Additional CPE details can be found here.

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SPEAKER_00:

Here on Game Changers, we're all about helping you stay ahead of pharmacy practice. But why stop at listening? You can earn CE credit for this episode and hundreds more by visiting CEimpact.com and logging into your account or creating a new one. Get credit, get inspired, and make your learning count. Hey CE Impact subscribers and welcome to the Game Changers Clinical Conversations Podcast. I'm your host, Rachel Maynard, and I'm excited to dive into our discussion today. And today we're going to be looking at the management of fibromyalgia, a chronic condition that causes widespread pain all over the body and affects millions of people in the US. But treatment for fibromyalgia can be challenging because there's no one cause and symptoms can be very different from person to person. And there are a couple of drugs that are approved for fibromyalgia, but it's been over 15 years since any new treatments have become available. And now another new option was recently approved. But we'll see that it's not actually a new drug or active ingredient. It's actually a drug that's been on the market for decades, but now in a new formulation, strength, and approved for a new indication. And so with that, I'll keep you on the edge of your seats for a minute. And our guest today will help us figure out where this new option fits in for managing fibromyalgia. And I'm thrilled to welcome our guest to speak about this topic today, Dr. Mandy Mullins. So welcome Mandy. We're so excited to have you.

SPEAKER_01:

Hi, thanks so much, Rachel. I'm excited to be here.

SPEAKER_00:

Fantastic. So, Mandy, maybe you can share a little bit about your background for our listeners to get to know you a little bit and your role, your current role, how you got into that position, and what made you interested in this topic.

SPEAKER_01:

Absolutely. So, as you said, my name is Mandy Mullins. I am a pain pharmacist by training. So I did specialize in pain management and palliative care. I currently work as a pain management and opioid safety coordinator at the VA Medical Center in Marion, Illinois. And within that comes a lot of different roles. A lot of them are more administration-based. However, I do still have clinics, and that is obviously targeting targeting, excuse me, our veterans in chronic pain. So I do see a lot of fibromyalgia in my in my daily workflow.

SPEAKER_00:

That's great. So we'll have some real life experiences, hopefully, to hear from you on that. Absolutely. So again, thank you so much for time and for joining us. And I think it would just be helpful to sort of lay the groundwork so we're all on the same page and maybe just give us a brief overview of what fibromyalgia is and what kinds of symptoms people have. And you know, then we can sort of think about how it's managed. But let's start with just that overview first.

SPEAKER_01:

Sure. So, you know, fibromyalgia really is one of the more difficult to explain and difficult to understand chronic pain conditions, um, really because it's something that we can't see, you know. So there's no physical component to fibromyalgia that is causing, you know, the issues and the symptoms that that we do experience. And so it is characterized by chronic pain, um, but also sleep issues, chronic fatigue, things of that nature that again are both adding or can add to that chronic pain element, but then are also very invasive in people's lives as their own symptoms. You know, so imagine not sleeping well daily or nightly and you know, having chronic pain on top of that. So it's it's kind of a vicious cycle of what do we target first? Um, and that you know depends on that, on that person specifically.

SPEAKER_00:

Yeah, and I I like how you said there's no there's no like markers that we can look for, no blood tests that can be done or imaging that can be done to to identify it. It is sort of a nebulous diagnosis based on symptoms, really. Would you say that's a good characterization?

SPEAKER_01:

100%. And you know, if you look at at the history of even diagnosing fibromyalgia, it took a long time for you know providers to agree that it was even a real condition because there's not something that says, yes, you know, you have this. So it is often referred to as a diagnosis of exclusion, but more and more, you know, as times are changing and as you know, we're getting better at recognizing fibromyalgia, um, it is you know becoming more common because we we kind of know what to look for.

SPEAKER_00:

And how often would you say that there is overlap with other conditions like depression, anxiety, other sorts of even like I guess is it autoimmune related or are the is it commonly a co-occurring with autoimmune conditions?

SPEAKER_01:

I would say definitely co-occurring. Um, and then you have some other conditions that kind of, I don't know, should make your spidey senses go off a little bit. You know, if they have that diagnosis, then fibromyalgia might also be there, kind of hiding, you know, within those different symptoms. So things like like chronic fatigue would be one, especially in women, because fibromyalgia is more prevalent in women. You know, the minute that you hear chronic fatigue, you know, something should kind of just you know tickle your senses a little bit, like maybe I should be looking also for fibromyalgia or thinking about fibromyalgia in that specific person. So, like a chronic fatigue picture, plus they have, you know, this chronic pain that doesn't really have a source, you're kind of then thinking, wait a minute, you know, we should evaluate this.

SPEAKER_00:

Okay. And in terms of management, you know, are there are there guidelines available for for treating managing fibromyalgia? And if uh where do you start in terms of thinking about management? Again, because it's such a multi-symptom sort of condition that's hard to really pinpoint, how do you start when thinking about management?

SPEAKER_01:

Yeah, it's a great question. Typically, I'm going to see what's most bothersome to that person. So if they have that diagnosis of fibromyalgia and they come in and they say, you know, for example, my pain is out of this world and and they don't have quite as much of, you know, the sleep issues, um, you know, other symptoms, then you know, maybe we'll we'll tr do our best to treat that pain as much as possible first and then you know address the other symptoms later on. Um, however, if someone comes in with you know their chief complaint is sleep issues, then you might target that reverse and hope that the pain kind of follows suit, you know, with once you get the sleep a little bit better controlled. But there are guidelines. Uh so this has really fallen to the rheumatology side to kind of manage and update those guidelines. And, you know, that goes back into really the history of fibromyalgia and back when it, you know, was first becoming more prevalent or more accepted as a diagnosis. No one was really claiming it because we didn't know where it fell, because we didn't have something to look at and say this is the cause of this condition. So it kind of fell into the rheumatology world. And so they still the American College of Rheumatology still kind of you know updates that and owns that along with the European society.

SPEAKER_00:

Okay, okay, interesting. Yeah, it's tough when it's such a murky sort of, yeah, like you say, diagnosis, and then nobody nobody really wanted it. Yeah, yeah, that's what it's unfortunate, obviously. So, but yeah, and and so in terms of so say you have a a patient who's sort of with that classic with the the characteristic of widespread pain, where do you typically start with managing that widespread pain, or how do you what are your first steps if that was your area of focus?

SPEAKER_01:

Absolutely. So you're looking at things that you know are previously approved for fibromyalgia specifically. So that includes Duloxetine, pregabelin, and then we also have milnasopran, which is still a brand name. But those are you know our three that are approved. Now, of course, we you know stray away from that often with the management of fibromyalgia, but really you're looking at okay, well, which one's best for this person? So just having even, you know, that those couple of medications that we do use, it's still gonna vary which one you're trying first in an individual based on, you know, what other medications are they on already? You know, what's their past medical history is something contraindicated at this point that I can't even think about. Um, so it really, it I mean, it really does just depend, which is, you know, the unfortunate reality of really anything in chronic pain management is that it's going to be different for everybody.

SPEAKER_00:

Right. And how about non-pharmacologic treatments too? Because it seems like that is a a core component of managing this condition, too. Would you agree with that? And if so, what what sort of patients do you start with for no farm?

SPEAKER_01:

Absolutely. And yes, actually, the number one recommendation for fibromyalgia is actually exercise. So that has exercise is what has been found to be the most beneficial in reducing pain levels, improving sleep, you know, improving the symptoms of fibromyalgia. The the problem with recommending exercise is that a lot of you know, those individuals with fibromyalgia, it's just not happening, right? It's not doable for some reason or another. And so then that is when we do kind of resort to the medications.

SPEAKER_00:

Yeah. Or at least to help provide some relief, perhaps to then get them started more focused. So that they can get up and exercise. Yes, exactly. Yeah, that's the challenge. And again, it's sort of this vicious cycle, chicken and egg situation where how are you going to start exercising if you don't feel well enough to move and you know, providing some sort of relief is hopefully where we're going with some of these treatments. And so you mentioned duoxetine and menalcyprin, which I are both the SNRIs, so working in that sort of on neurotransmitters, I guess, is the way that they're working to provide some benefit. And pregabolin, you said was the third. So maybe in terms of how those are thought to work for those symptoms, it and then we'll talk about the the new drug that was recently approved, but maybe just putting those in perspective in terms of their mechanism and how that ties into the potential benefit that we would see.

SPEAKER_01:

Yeah, yeah, sure. So that could be a really, really long, in-depth answer, but I will try to try to make this try to make this as short and sweet as possible. But so you have things like dualoxetine and milnasocrine, like you said, that are you know classified as SNRIs, which stands for our serotonin, norepinephrine reuptake inhibitors. Um, those when you're looking at the pain pathway specifically, so you know, from the minute that you know something goes wrong in our body to our brain's response to that, all of that in the pain pathway, you will see both serotonin and norepinephrine involved in that process. And so the easiest you know, way to think about it is serotonin and norepinephrine are a lot of our or some of our feel-good neurotransmitters. And so by by increasing that in our body is going to help then decrease our pain signaling. And so that is, you know, again, one of the ways that that those are working to decrease our pain levels. Um pre-gablin specifically is is working and has a part in that pain pathway. So a lot of the the same end goals, but they're going about it differently through different pathways.

SPEAKER_00:

Okay. Okay. Well, that's a helpful overview. And again, complex complex condition, complex sort of treatments and how they might fit in, but I will sort of get to the punchline, which is the fact that we have this new drug, again, uh first drug available approved for fibromyalgia specifically in over a decade. And it is cyclopenzoprene sublingual tablets. Um, the brand name is Tamaya. And when we think about cyclobenzoprine, how what has been the role of cyclobenzoprine to date for fibromyalgia? And then what is sort of different about the sublingual formulation and what advantage is that supposed to provide, if any, and and sort of helping us understand the role of that that drug in general for fibromyalgia?

SPEAKER_01:

Sure. So, you know, cyclobenzoprine is has been like around for a long time in its you know oral form, in the tablet form. So when thinking about fibromyalgia, you know, there are situations where cyclobenzoprine is used and it it can be used quite effectively, even in like that oral tablet form, mainly when thinking about like sleep issues. And you know, one of the main complaints of cyclobenzoprene as a muscle relax in itself is that it's causing too much drowsiness and folks can't take it during the day because you know they can't tolerate it because of the needle to sleep. And so really in fibromyalgia, we're using that then just to our advantage. So we're using that side effect to hopefully help with any sleep concerns you know that somebody might be having with fibromyalgia and giving that to them. One of the issues with the oral form again that was already approved is really again just the sleep issues. You know, sometimes the doses, you know, we can't really go as low maybe as we want to with some of those doses for tolerability concerns. So I think, you know, this new sublingual option, which is lower doses than what is already available in the tablet form, you know, it it could hold a place in in fibromyalgia treatment. You know, we're we're gonna have to see. It's it's exciting. It is exciting to have a new option.

SPEAKER_00:

And of course, there is always, you know, the initial studies that brought it to approval. And then, yeah, seeing what's actually happening in real world practice and how it plays out in in patients who are taking it. And then also the the question about long-term safety, too. We we learn as we go in some time in some cases. Obviously, we have a lot of data with cyclopenzoprene oral tablets, but in terms of the new formulation, you know, we'll have to see risks and benefits there. So, but specifically that sublingual form, is is there any difference in terms of what patients like in in the the onset effect or duration or anything like that that that would make that a distinction from the oral tablets? What what could we learn from there?

SPEAKER_01:

Yeah, absolutely. So, in you know, I looked at the trials that that got it approved. Um, they did find, you know, that the onset was a lot faster than the you know than the oral tablet, which makes sense. You know, it's a sublingual product. It is it's getting into our system a lot quicker, you know, than swallowing a pill and letting it go through that process. So it is getting into the system quicker, which means it is gonna have that quicker onset, which is which again is good if you're using it, you know, in this case, like for fibromyalgia, for sleep, then it is good because we want that to come on, you know, so that you know, we we're not having to predict, okay, how long do we think that this is gonna take, you know, to kick in? What time of day do we take it? So that you know, we're timing it appropriately. So that is helpful, you know, that it is that route of administration and that you know it's a little bit more predictable for us.

SPEAKER_00:

And as you say, it is it sounds like it's primarily helping with the sleep component and supporting better sleep. And so it is something that's taken at bedtime before sleep, and so again, hopefully would have the effect to support sleep after being taken, and again, hopefully a little bit different onset perhaps. So, in terms of the studies that brought it to market and allowed us to see, you know, what kinds of benefits are we seeing, and and was the benefit primarily in sleep, or did we see any difference in pain, or how what if you could describe those those studies a little bit to help us understand? Sure.

SPEAKER_01:

So they you know they were all slightly different and found slightly different things. So sleep was kind of you know, like the the unanimous yes, we found improvements in sleep, which is kind of as to be expected, just based on cycle benzoprina itself. Um where the studies started to differ a little bit was actually in their benefit on actual pain levels or the pain scores. So one study found a statistically significant improvement in pain levels. Um what's interesting about the global impression of change, the patient, the global impression of impression of change, excuse me, which is just a a a one question tool that is used to assess how much that person feels like they have improved. So um, you know, it tells you kind of where their mindset is at a little bit more. And that did not improve in one of in one of the trials, which was interesting because even with you know, some benefits in in the other symptoms, they were still feeling like I'm not sure that I I'm any better.

SPEAKER_00:

Yeah.

SPEAKER_01:

Yeah. So a little bit interesting there, but overall the sleep the sleep looked good from what you know what those trials were saying. So I think you know, time will tell. You know, it's tricky because fibromyalgia is also something that you know comes on stronger and then gets better and then comes back, you know, a little bit stronger. So it waxes and wanes a little bit, um just naturally. So it's really just hard to tell, especially in like the clinical trials that are maybe only following somebody for 12 weeks, you know, what is actually the bigger picture of this.

SPEAKER_00:

And to get to that, so as you said, if these trials are relatively short term, do we have do we have any longer-term data, or we just have to sort of wait and see how once it's out in the wild, what we're gonna do?

SPEAKER_01:

We're gonna have to get it out in the wild and see how it does. Yeah.

SPEAKER_00:

So and that is another consideration because not only is it a question of safety or efficacy after those 12 weeks, but also safety considerations and what what that might pan out to be, because most people historically, I don't think of cyclobenzoprine as something you would take long term necessarily. Maybe for fibromyalgia, we do have some experience with it in a longer-term setting. Uh, what's your been experience been your experience with that?

SPEAKER_01:

Yes. So, you know, in the in the chronic pain world, we are told not to use a lot of things long term and we end up using them long term. Right. Because, you know, that's just the nature of the beast, I guess, because you know, chronic pain is not going away. Um, so you know, it's it you need that treatment for it. So if it says not to use it long term, or I believe most, if not all, of your muscle relaxants as a category or as a class actually say do not use for longer than seven to anywhere to 14 days. And it's like, well, you we are. Um and so we just we continue to monitor, you know, make sure that they are tolerating it okay, make sure that you know, we're not adding things else on adding anything else on board that can, you know, contribute to some additive side effects or things like that. So um so yes, I'm time will tell how it does again, like you said, in the wild, you know, in real life circumstances, but it it is nice to have that option because you know, the dosing for the sublingual cycloben soprene is lower than our tablets, like we said. So with that, you know, I'm hopeful that it will be better tolerated long term because it's not something that I see being started and then stopped.

SPEAKER_00:

Right, right. And even in the labeling, and just to you know say what the dose is, it's a 2.8 milligram tablet, sublingual tablet. And I think patients start out with just one tablet once a day for two weeks at bedtime, and then go up to the two tablets once a day at bedtime is that target dose. And then again, yeah, nothing in the labeling that I saw about like how any duration specified. So it is something we might see patients on longer term potentially if it is supporting helping with their symptoms. Absolutely. So it is that bedtime medicine. But we talked a little about the mechanism of those other approved drugs. Let's just briefly touch on how this drug also helps. You mentioned sleep and the sedative effect, but is there any other sort of is there any effect on serotonin, norepinephrine with cyclobenzoprine or any other sort of mechanistic effects that we might think could be helpful?

SPEAKER_01:

Yeah. So, you know, cyclobenzoprine for fibromyalgia, really cyclobenzoprine as a whole, you know, we have some guesses of of how it's working. Um, but and not to, you know, go too too broad, but a lot of our muscle relaxants just in general, we're like, okay, well, we think it does this, but we don't really a hundred percent know for sure. But cyclobenzoprene, we know has like some centrally acting effects. So it's working on our brainstem to to do a couple of different things. Um obviously one of those side effects is the drowsiness. But it does have some like serotonin involvement or effects. It also has some like adrenergic um, you know, it it works on a myriad of different receptors. I mean, it it does like so many little different things that it's really kind of hard to conceptualize sometimes because you're like it's all just so intertwined. But it does, it does have some serotonin involvement. Yes, yeah. So, you know, benefit usually when we think of it in like pain management or chronic pain, usually you're actually thinking about like the actual like muscle activity that it has, as you know, hints at being a muscle relaxant. And so most often, you know, you're seeing it used for other painful conditions that are actually involving your muscles, whereas fibromyalgia is going to be more of like those background pathways, like the serotonin involvement, you know, maybe some brainstem involvement in in reducing like that pain signaling.

SPEAKER_00:

Gotcha. Okay, so and I think that's actually a really important point because one of the considerations and warnings in the labeling is around concomitant use with other serotonergic drugs. And I would imagine, based on what we talked about before, in terms of the common treatments for fibromyalgia that many patients might also be, even not for fibromyalgia, but for these comorbid conditions, they may be on other medications that have serotonergic effects. So, how would you like say that interaction seems likely like it would pop up in a pharmacy software system? So, how do you address that? What is your thought process if a patient gets this new prescription for cyclobenzoprene and then is already on an SSRI or SNRI for any other reason? What is the significance of that warning?

SPEAKER_01:

Yes. So I can tell you that happens all the time. Yeah. Right. We we get the serotonin syndrome warning probably more than you know anything else. Yeah. Because, you know, again, in chronic pain, a lot of our medications, because we're trying to influence that pain pathway, are, you know, interfering with serotonin in some way, shape, or form. So we do get that a lot. Um and you know, it's one of those things where where you do have different kind of incidence rates with different medications on, you know, are they are they likely to go cause a serotonin syndrome, or is it more of a it can, but usually we don't see it. And so I would say cyclobenzoprina is in that, you know, it it theoretically can, but we don't see it super often category. So you know, if I got that warning with like cyclobenzoprin and like zoo-loxetine, for example, because that's a another very, very common one. I'm gonna give it some thought. I'm gonna have that discussion, you know, with that person with that we're we're starting on it, and just educate them, you know, on the signs and symptoms of serotonin syndrome. Um stop, you know, stop probably the cyclobenzoprene, you know, immediately if you do experience those symptoms. But overall, it's not something that I'm gonna actually expect to happen very often. But, you know, even saying that, it's something that you definitely want to make sure that they're aware of because, you know, if they're not and then it happens, then then that's a problem.

SPEAKER_00:

Well, and it's one of those things that uh there could be some other factor that then tips them over into that higher risk category, especially if they get any other medication added on, and maybe they've been stable on a couple of medications, like the like you said, daloxetine and cyclobenzoprine, if they've been stable and then another serotoninergic med is added on, then it sort of increases that risk. So absolutely making sure that patients are aware of some of the most would you in terms of counseling, would you focus on a few specific sort of symptoms that they should be watching for and alert their providers?

SPEAKER_01:

Yeah, I you know, the ones that I typically educate on are like irritability or like you know, snappiness, right? Because a lot of the times if if someone has a spouse, they're they're some of the best like information givers about that person, you know, sometimes over what what they think, you know, they're like, no, you have been like you know, snappier lately, or you've been, you know, more irritable, things of that nature. So irritability is one that I that I like to watch for. Um, just like some sweatiness, claminess, you know, like generally just not feeling well and like feeling off. Sometimes just you know, telling them to be mindful of that, you know, is is enough because that kind of like encompasses a lot of your like sign-ins and symptoms of serotonin syndrome is just that general feeling of something's not right. And you know, you're sweating and you know, you can't figure it out, and you're kind of, you know, your mind's racing. And like that's the perfect, you know, situation or example of like one of the some of those first steps in that process.

SPEAKER_00:

Yeah. And so educating, and again, that alert will probably pop up every single time you dispense those medications together. So, you know, counseling them upfront when they are receiving that, but also taking that opportunity, I think, as they show up for any refills to remind them, hey, you know, if you ever are feeling off or feeling sweaty or jittery or, you know, tremors at all, you know, those kinds of things, just report those right away. And, you know, it doesn't necessarily mean you have serotonin syndrome or that that's happening, but just to be aware of some of those things to be watching. Right. Exactly. So we we sort of transitioned into some of the counseling points. And I I think that makes perfect sense because there are some unique considerations with this drug. I think another one is that CNS depression, which again makes sense given how we're sort of looking for that as a potential benefit in helping with sleep. But what should patients know in terms of that potential side effect and how to manage that or prevent it?

SPEAKER_01:

Yeah, so it's a great question because, you know, especially where we're at in our current climate right now, you know, with pain management and the opioids and everything that's going on, there has been some evidence that has come out that opioids in combination with muscle relaxants, so things like cyclobenzoprene can, you know, increase that risk of respiratory depression, which we don't want. Opioids typically are not recommended for fibromyalgia treatment. However, fibromyalgia, kind of like we talked about earlier, comes with so many different symptoms that sometimes opioids are prescribed. And sometimes that's the only thing that they have found that is actually helping with their pain up until this point. And so it is a situation that I can almost guarantee that you know, we will run into is that somebody is getting this cyclobenzoprine on top of opioids main or possibly other stuff, you know, that can cause CNS depression. So in that case, you know, just educating on feeling over overly tired. So not just like the normal, you know, I can snap out of this and and go about my day, but like unable to continue on that level of drowsiness is a concern. Um you know, following evolving obviously a concern, but that hints at something that is more than just like the drowsiness side effect of Cyclobin Supreme, if that makes sense. So kind of giving some of those real life examples really helps. Helps I think people picture like what exactly you know where that line is drawn, what's concerning versus what's expected. And so in that case, always asking for a naloxone prescription is a good idea if you're on that opioid in addition to the cyclobenzoprine. But other than that, it's just a lot of education on, like I said, where where is that line from this is a good option to help us sleep to okay, something's not right.

SPEAKER_00:

Well, and I think also having patients take stock of where their baseline is, as you said. So knowing sort of before starting any new medications, taking stock, maybe even jotting down, you know, the severity of their symptoms and how they feel at that time before they start. And that not only can help them understand if they're having potential side effects, but also any potential benefit that they might or might not be seeing. Absolutely. Yeah, absolutely.

SPEAKER_01:

That's a great point because it is, you know, it's all about the change. And so, yeah, in either direction, good or bad, we want to know. You know, we want to know what's improved, what what's not improved, or what's got worse because we we want to fix it.

SPEAKER_00:

And that seems like such an important point, in particular with fibromyalgia, just because it is hard to quantify in any other way. And so, really, sort of having those patient assessments, self-assessments, seems like a really important thing for them to be aware of and for them to be doing. Alcohol is another consideration, obviously, for the same reason. So, again, you know, if you say a person is thinking about having a holiday drink, how would you handle that situation? And again, is it just education, just making them aware of the risk? And and again, sort of that tipping the balance potentially with a few concomitant things happening. What is your typical approach for that?

SPEAKER_01:

Yes, you know, you know, the best answer is to say, well, just don't do it, right? Don't don't have the holiday drink. But you know, is that realistic? And that's where you get into okay, where are we gonna find some common ground? Because, you know, if somebody wants a holiday drink, you know, at what point does your quality of life, you know, take over versus like what medications you're taking? And you know, it's just something to consider. But you know, I have found that that most of these people, right, they know their bodies in in a sense that they know that they can have a beer or a glass of wine or like a festive drink and then call it after that and and not have any issues. And so I'd say a lot of you know, talking about like history, about okay, well, like do you know where that point is to where yeah, you know, we should say no more? And if they do and and you have that good relationship with them, and you know, you can have those open and honest conversations, then really, I mean, that's all you have to go off of, right? Because you can tell them don't have that drink, but then if they're just gonna turn around and have that drink, I'd rather, I'd much rather have the conversation of, okay, well, let's let's figure out how many, you know, can we have one or two drinks and then call it after that and kind of find like a you know a shared decision-making approach basically to find like that answer of okay, what are we gonna do in those situations?

SPEAKER_00:

Exactly. And you know, I this is like the recurring theme I'm hearing from our conversation is this individualization and very personalized conversations that shared decision making, I think is so important with some of the considerations in terms of safety and interactions that we've been talking about. And I another one too is you know, I think in the the label it says about not driving or doing any, you know, that standard language about not driving or doing anything that requires concentration until you know how this affects you. And again, it's a very like you say, patients know their bodies. So having making them aware of that, but also having them understand, you know, this is a risk, but if you're aware of how what your baseline is and and whether that changes, you're gonna have the information needed to know how to go forward. So yeah, definitely some challenging considerations there that I think will come up with when talking with these patients. And so to sort of wrap up the the sort of management of fibromyalgia and this drug in particular, considerations with that. Let's talk about some of those other specific counseling points that are really important with this drug and maybe what's unique about it too. So that's some bigal formulation. I think it has some unique considerations just by the fact that it's sublingual. So maybe you can talk about a few of those points that we want, especially if you know pharmacists have never seen this drug and not dispensed it. What would be those key things that we should be reminding patients about?

SPEAKER_01:

Absolutely. I think, you know, first and foremost is that it's not to be swallowed, right? So anything sublingual, don't swallow it, right? It's not meant to work that way. It is formulated different, it is not equal to a tablet. So, you know, if you've never had a sublingual medication before, you know, it is different, right? Because you have to give it time. And it, you know, you can't just swallow it with a glass of water. So, you know, actually counseling on the administration, I think is probably the most important thing in this case, since it is different. And since honestly, many of these patients with fibromyalgia that maybe started on this are probably have taken cyclobenzopreneurs than that.

SPEAKER_00:

Yeah.

SPEAKER_01:

You know, and so just kind of educating on the differences. Um you know, again, namely sublingual. So stick it under the tongue, let it dissolve, let it, you know, do its thing. And then, you know, aside from that, I think just educating on this is gonna hit you faster than what like that P.O. tablet was gonna do. So, you know, don't take it at dinner time. You know, wait until you're actually until you're actually going to bed before you take this, because it is going to, you know, like I said, that onset is going to be a lot quicker because with that sublingual route, it is getting into our system much, much faster. And then, of course, educating on the drowsiness and and why that may be helpful and the you know, the fact that that is what we want, because as we all know, right, a good night's sleep can do a world of wonder for you know a lot of our other symptoms.

SPEAKER_00:

Yeah. And again, thinking about that vicious cycle and and trying to nip that in the bud a bit with helping with sleep. Yeah, and I I think it's it's helpful because it's taken at bedtime. So some of those considerations, like there's a uh comment in the labeling about not eating or drinking for at least 15 minutes and not having any hot, cold, or acidic beverages until the morning after. And I thought that was interesting. Sort of thinking about it similar to think like nicotine replacement therapy has the same sort of warnings. Yes, yes. And so, you know, that might not be something patients think about at all. And so letting them know this is why it's taken at bedtime partially, so that you just go to bed and you don't have to think about consuming anything else that might affect how that drug is being absorbed. Um, but also tying that back to some of the other side effects that patients may see, I think, like some tingling or numbness, some of those types of side effects are quite common. Maybe you can speak to that a little bit.

SPEAKER_01:

Absolutely. So, you know, with the sublingual, you know, route of administration, since it is formulated differently, you know, we are gonna have different chances or risks of some of like, you know, what we would call like those local side effects, right? It's like when you get an injection of, you know, your flu shot, whatever it may be, you know, the number one concern or side effect possibility is like that injection site reaction. It's kind of the same concept. Yeah, that's a great analogy. Yeah, it's kind of it's the same concept that you know what, at the site of action, there might be some of what you just said, kind of like the tingling in, you know, in your mouth. It can happen. Um, and it did happen, you know, in the studies that got it approved. So it's you know, it's not going to be a huge surprise if that continues to happen as we use it in real world scenarios. So I think that one I also saw some dry mouth or potential. Um so yeah, a lot of like different mouth things. Now, is that reason to stop taking it? Not necessarily, not unless it becomes, you know, so overbearingly painful or you know, you can't your mouth doesn't go back to, you know, getting some saliva, then then maybe that is something that we need to consider and you know, try to figure out. But um, you know, most of them are going to be tolerable.

SPEAKER_00:

Yeah. Yeah. And and same. I love that analogy of the injection site reactions because they're tolerable, you know, go away and not necessarily something that's going to prevent you from getting uh an injection. And I think, you know, one thing I it looked like the labeling was suggested having the mouth be moist, so having a few sips of water before taking. So if a patient is complaining about some of those oral symptoms, there are some strategies that we can suggest to help manage those. And like you say, just being aware of that. And if that's happening, you know, maybe there's something with the administration we can help them help them through. You know, the other thing I think is worth mentioning in terms of the counseling points and awareness, especially because you did mention that fibromyalgia is more prevalent in women, is the pregnancy considerations and warnings around this drug. And I I don't know that they're necessarily different than what we might have seen with cyclobenzoprine originally, but the labeling is quite specific in terms of making sure patients have a pregnancy test before they start this and that they're using contraception. So where is that coming from? And and help us understand what to tell patients there.

SPEAKER_01:

Yeah, absolutely. So cyclobenzoprine itself, so whether sublingual or not sublingual, you know, or oral, is is not recommended in pregnancy because it can cause, I believe it was like neuroneural tube defects. So not something that we want to take if we are, you know, trying to get pregnant, pregnant already. So yes, a pregnancy test would be a good idea if that's needed, unless, you know, there's you know, unless we're postmenopausal, you know, have something else that would obviously not allow us to get pregnant. But yes, something definitely to be considered.

SPEAKER_00:

Yep. Yeah, I just thought it was interesting to see that specific recommendation about making sure if you can get pregnant that you're on birth control and at least throughout the course of treatment, I think for two weeks afterwards as well, after stopping it. So important consideration again for a lot of this population. All right. So just for the sake of time, I think we'll start thinking about one question that I think might come up is say you do get a prescription for the sublingual formulation and it's not covered, which we know can be common with new drugs, especially that are brand name only. Is there any what would you do in that situation? And say, you know, we'll try for the prior authorization if that's something that the insurance is requiring. But if that doesn't go through, would you think about off-label use then of cyclobenzoprene as an alternative? And you mentioned that it has been used historically, and so how would you help navigate that situation?

SPEAKER_01:

Yeah, that's you know, that's a great question. And that's something that I do see happening because, like you said, you know, people are always trying to find ways around, you know, okay, what can you do that's similar to this until we can get this one, you know, the way that we want it, right? Right. So it's a great question. I think, you know, if I were in that situation, I would, if I thought that cyclobenzoprene sublingual was going to help them, you know, I would go for it because why not? Right. You know, you you do have to kind of make your case. So, like, why aren't, you know, some of the other options that are approved for fibromyalgia are being used, whether that be contraindications or failure of of that therapy already or whatever it may be. Um but yeah, I think you know, I would go for it. And if if it is turned down mainly because of price at this point is what's probably gonna be the issue, then I think you know, given the oral for cyclobenzoprene consideration isn't a bad option. Like we kind of talked about earlier, it is gonna take a little bit more of the educated guests work to uh, you know, get the dose right, get the timing right, get the you know, the administration right. Whereas, you know, this one is going to eliminate a lot of that okay, what time do we need to take it?

SPEAKER_00:

You know, do we take it with dinner?

SPEAKER_01:

How how quickly is it gonna affect you, you know, on those different questions? So you know, it's not something that probably can't be worked around, but it would be more difficult for sure.

SPEAKER_00:

Yeah, yeah. And it's not, it's definitely not a one-to-one conversion because they're different different strength altogether, 2.8 milligrams versus the lowest strength of the tablets is five milligrams of the oral tablets. So yeah, it would take some discussion with, you know, the prescriber and or you know the other clinicians working with the patient to make sure that they're getting the intended effect if they are gonna do something. Yep. All right. Well, bottom line, what would you tell, you know, me as a colleague, and I'm like, what is this new drug and where is it gonna fit into managing fibromyalgia? What would you be your 30-second bottom line?

SPEAKER_01:

Oh gosh. I think, you know, I would say if if your primary concern is some sleep issues, then this would be a good place to potentially start. Um, because none of really none of the other ones that we use or that are approved for I'll say approved for fibromyalgia really target the sleep aspect, right? Most of them are are targeting like the actual chronic painful condition part. So if you have something on board that pain is not their primary complaint and really sleep is, then then this would be kind of the route that I would go down in that scenario. Um yeah, I think I would just tell you to focus on whatever symptom is is most concerning to that person at that time.

SPEAKER_00:

Right. Okay, great. And it goes back to that point about individualizing and personalized care and decision making, all of those good things.

SPEAKER_01:

Yes.

SPEAKER_00:

And so are there any other game changers outside of that bottom line, any other game changers that you'd want people to walk away with on this discussion?

SPEAKER_01:

I think I yeah, I I would just again reiterate the bottom line is that what you think might be most important to somebody, it might not be what they think is most important, especially with fibromyalgia that has so many different symptoms that you know present at different times. And realizing that, you know, one visit somebody might be concerned about sleep, the next visit they might not be. And that is very normal and you know, just something that we have to balance and you know, and getting them a better quality of life.

SPEAKER_00:

I love that. Yeah, and that goes back to the idea not only of symptoms can change, personal focus can change, but also the waxing and waning that can happen too. And so yeah, empowering patients, I think, with with the tools they need to be able to monitor themselves and help us help them get resolution for some of that.

SPEAKER_01:

Yeah, for sure.

SPEAKER_00:

All right. Well, thank you so much, Mandy. This was a great discussion and definitely learned a lot about this this new product and where it might fit in. So thank you so much. Really appreciate your time.

SPEAKER_01:

Yeah, it was fun. Thank you so much for having me. Excellent.

SPEAKER_00:

All right. Well, listeners, be sure to claim your CE credit for this episode of Game Changers by logging in at ceimpact.com. 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.