2025 drug trends wrap-up: Behavioral health and beyond

Yenney, Cameron R   0:00
All right. Good morning. Good afternoon, everybody. And thanks for joining us for our quarterly clinical webinar. Today, we're going to cover current drug trends in the behavioral health and what you need to know. My name is Cameron Yinny and I'm a clinical pharmacist with General Healthcare. Prior to my current role, I worked as a site manager in Seattle, WA.
And I had the opportunity to support both clinical operations and patient care. I'm excited to be here today to discuss drug trends in the behavioral health field and share insights that might help you navigate this evolving landscape. Joining me today is Nancy Mixon, one of our outstanding Site managers.
Based in Canon City, Co. Nancy, I'll pass it over to you to introduce yourself before we dive into today's content.

Mixon, Nancy   0:41
Hi, I'm Nancy Mixon. I am a Site Manager in Canyon City. We got some fun snow going on here. Hopefully everybody's weather is great for them. Um I've been with Genoa for just over a year. I opened my site in October of last year and we've been steadily growing. I am so happy to be with the company and be to um give that little bit more hands-on clinical role.

Yenney, Cameron R   1:08
Thanks, Nancy. Let's go ahead and get started. We're going to get started with just the FDA drug approval process. So the drug approval process in the United States is a multi-phase journey overseen by the FDA, specifically at Center for Drug Evaluation and Research.
It begins with the preclinical phase, where researchers conduct laboratory and animal studies to assess the safety and biological activity of a new compound. If the results are promising, the drug sponsor submits an investigational new drug application to the FDA. This outlines the plan for human testing.
Once the IND is approved, the drug enter clinical trials, which are typically conducted in three phases. Phase one focuses on safety and dosage involving fewer than 100 safe healthy volunteers. Phase two evaluates the drug effectiveness and side effects in several 100 patients with the targeted condition.
And then phase three expands the study to thousands of patients across diverse populations to gain comprehensive data on safety, efficacy and potential interactions. If the clinical data supports the drug benefit, the sponsor submits a new drug application for FDA review.
A team of FDA scientists and clinicians in thoroughly examined the data, including manufacturing standard and proposed labeling. If approved, the drug can be marketed, but the process does not end there. The FDA continues to monitor the drug through post surveillance marketing, which includes.
Adverse event reporting, periodic safety updates, and then sometimes additional studies known as phase four trials. This ongoing oversight ensures that the drug remains safe and effective as it reach broader patient populations in real world settings. So like with all these steps involved from early research to final FDA approval, it can take up to.
15 years for a new drug to move from initial invention to being available on the market. To illustrate the pace of approval, this graph from the FDA shows how many new drugs have been approved in the past decade. So as you can see, in 2023 the FDA approved 55 new novel drugs. In 2024, there are 50 new novel drugs.
This data, along with the visual, is available directly on the FDA's website and offers a great snapshot on how active and complex the drug development landscape really is. So we're going to stop here and take a poll with knowing how many drugs were approved in 2023 and 2024. I want to know how many drugs you think were approved.
In 2025 so far, I think it's 273339 or 45.
So as you guys kind of answer, you can find this answer really quickly by just Googling FDA new drugs in 2025 and you'll see a list of everything that was approved in 2025 so far, I think with the most recent being.
11/25/25 So just very recently, the last week or so.
So I see answers coming in. I see 45 as being the most answered. The answer actually is 39. So like I said, you Google it real fast, you'll be able to pop up that website and you'll see real quick 39 with the most recent being 1125 being approved.
So with that, let's go ahead and jump in with one of the drugs we saw approved in 2025. First drug we're going to talk about is Gernovax. It's a first in class oral non opioid analgesic approved for moderate to severe acute pain in adults. It represents a major advancement.
In pain management, offering a new mechanism of action that avoids the risk with opioid use. This approval is based on clinical studies evaluating the safety, efficacy and PK profile of Gernavax, a highly selective NAV 1.8 sodium channel blocker.
Now this sodium channel blocker is expressed in peripheral sensory neurons and plays a key role in transmitting pain signals. It works by targeting this pathway before pain signals reach the brain, making it the first drug approved in this new class of pain medications.
Jurnavax has been shown to be effective in treating acute pain caused by either surgery, injury or other conditions with a safety profile that supports its use across a broad population. The most common adverse events include nausea, dizziness and headache, and importantly, Jurnavax damaged.
Created no evidence of a potential addictive potential, distinguishing it from traditional opioid treatments. Compared with existing pain medication, Dronevax offers a non opioid alternative with a novel mechanism of action and a favorable tollability profile.
It's approval marks the first new class of pain medications in the in over 20 years, and it is expected to play a significant role in reducing reliance on opioid for acute pain management. Next drug we're going to talk about is yes to go.
Yes 2GO is the first and only FDA approved long-acting injectable for HIV prevention that provides protection with just two doses per year. It represents a major advancement in pre-exposure prophylaxis for HIV one offering a convenient and effective alternative to daily oral medications.
This approval is based on the results of Phase three, Purpose one and Purpose 2 trials, which enrolled thousands of participants across diverse populations. These studies demonstrated that Yesugo, a capsid inhibitor, was highly effective in preventing sexually acquired HIV infections.
With over 99.9% of participants remaining HIV negative during the study period, YES2GO is indicated for adults with adolescents waiting at least 35 kids who are at risk for HIV one. Now YES2GO differs from other PrEP.
Options by offering a twice yearly subcue injection significantly reduce the burden of adherence compared to daily or monthly regimens. It's long acting formulation targets the HIV 1 capsid, a novel mechanism of action that disrupts multiple stages of the viral life cycle.
The safety profile of Yes2go was consistent with previous finding of lencapavir. The most common adverse reaction include injection Site reactions, nausea and headache. Importantly, individuals must be confirmed HIV negative before initiating Yes2go and before each subsequent injection as using an undiagnosed.
HIV-1 infections may lead to drug resistance. Yes, Tubo's approval marks a transformative step in HIV prevention, and especially for individuals who face challenges with daily adherence or prefer a discrete long-acting option.
Nancy, I know you're out in the field. Have you seen either of these medications being prescribed or what other information do you have on these two?

Mixon, Nancy   8:07
Yeah, so we did have a question about the Jornivax and how it works. It is, it blocks at the neuron, so it blocks the signal from going to the spinal cord and brain. Um And then the biggest thing with that medication
is that it does interact with a decent amount of your um psychiatric medications just because of how it's processed, and a lot of the psychiatric medications will increase the processing time, so you just kind of want to keep an eye on that.
Doesn't mean you can't use it, just means you got to make sure it's actually going to work for the patient. And if you have any questions about whether it will interact, you can absolutely talk to your site pharmacist. As far as the ES2GO goes, I have not seen it. Umm I do know that it is one of those where
Gilead allows for, um, certain pharmacists to, um, inject in place of them going to the provider, um, and there is a website, uh, through Gilead to give you, um, where you can go or send your patient if for whatever reason they need
Patient if for whatever reason they needed it and you guys were closed and Genoa is certainly on that list.

Yenney, Cameron R   9:32
Thanks, Nancy. I believe at the end of this presentation, we'll provide that link for that website. So if you guys are interested, make sure you look at that and it can guide you to that website. So now that we've seen what's hit the market, let's take a look on what's on the horizon.
The pipeline gives us a preview of medications that could reach the shape behavioral health in the near future. First, we're going to talk about Celtorexant. It's a treatment targeting major depressive disorder with insomnia symptoms acting through a novel mechanism as a selective Orexin 2 receptor antagonist.
This unique approach aims to regulate sleep and mood by modulating the brain's arousal system, offering a potential alternative to traditional antidepressants and sedative therapies, unlike conventional treatments that offer.
Often affect multiple, multiple trends neurotransmitter system. Cell Terexant works specifically on the Rexin pathway, which plays a key role in wakefulness and sleep regulation. By selectively blocking Rexin 2 receptor, Cell Terexant may reduce hyperarousal and improve sleep quality without the sedated burden seen in other agents.
Clinical trials have been showing promising results. In a recent study, cel-torexant combined with an oral antidepressant demonstrated a greater response at week 26th compared to adjunctive Q-typine XR. With fewer side effects such as weight gain and somnolence, its safety profile had been.
Favorable with most common adverse events, including mild nausea and headache, Celtrexant is currently being evaluated in phase three trials for adults and elderly patients with MDD and insomnia symptoms. The trial aims to further establish its efficacy and tolerability as an adjunctive therapy. If successful, it could become.
The first in class options for patients struggling with both depression and sleep disturbances compared to other agents like Eutiopene or benzodiazepines, targeted mechanisms may improved tolerability and reduce risk of sedation or dependency.
Its development reflects a growing interest in precision psychiatry, where treatments are tailored more specific symptom clusters and biological pathways.
Alright, next we're gonna talk about is a new olanzapine long acting injectable. Now there's already a long acting injectable form of olanzapine, so I wanna know what's the biggest barrier for you when prescribing the current long acting injectable.
At your clinic.
So is it post injection monitoring requirements? Is it the risk of post injection delirium, sedation syndrome, insurance or prior authorization changes, patient reluctance or the adherence concerns? Or this question does not apply. I don't prescribe long acting.
Injectable of a land speed.
Seeing the answers come through, I did wanna point out for the the people out there, the clinicians out there choosing insurance or prior authorization challenges, our general pharmacies are great at helping with.
You know, completing authorization challenges or you know, being a great resource for you. So please reach out if you're experiencing that and to your local general healthcare and they might be able to help you solve some of those issues.
So with the current formulation, there is the risk of the the post injection monitoring requirements and the risk of post injection delirium. So that's why I wanted to bring up this new medication in the pipeline, a new form of olanzapine.
A new long acting injectable known as TAV 749 and it's nearing FDA submission and could offer a safe, safer, more convenient option for schizophrenia treatment. Unlike what's currently available, this new formulation is designed to eliminate the need for post injection monitoring developed by Teva.
Teva 749 is a once monthly sub Q olanzapine LAI and it most recently completed the Pivotal 3 Solaris trials, which evaluated its efficacy, safety and tolerability in adults with schizophrenia. The study showed positive results with no reported cases of post injection delirium sedation.
Syndrome, a serious risk associated with the older IM formulation. This new LAI uses new technology to deliver a LENSP in a controlled, sustained release manner. The absence of PDSS in the trial is a major advancement as it could eliminate the current requirement for a three hour observation.
period after each injection. This change would significantly improve convenience for both the patient and the provider, potentially increasing adherence and access to long-acting treatment. TEVA is expected to submit a new drug application to the FDA in quarter four of
25 with the hopes of bringing TEV 749 to market shortly after. If approved, it could serve as an estimated 20 to 30% of the patient currently on oral olanzapine who may benefit from a long-acting injectable option.
Next in our pipeline is a drug called CYB 003. It's a next generation psychedelic compound being developed for it being developed for the treatment of major depressive disorder designed to improve upon traditional psilocybin therapy. It is an analog of psilocybin, meaning it has been.
Chemically modified to enhance stability, reduce availability, ensuring the duration of psychedelic effect while preserving therapeutic benefit. It acts as a 5H2A receptor agonist, agonist targeting serotonin pathways that influence mood, cognition, and emotional processes.
Unlike conventional antidepressants that require daily dosing and may take weeks to show effect, CYB 003 is intended for intermittent administration, potentially offering rapid and sustained symptom relief with fewer doses.
Now phase two trials demonstrated significant improvement in depressive symptoms with high and high remission rates with a favorable safety profile and no serious adverse events were reported. These results support ongoing phase three paradigm program, which includes 3 pivotal studies, approach, embrace and extend focused on patients with.
Moderate to severe MDD who have not adequately responded to standard treatment. Its formulation allows for oral administration, a key advantage over traditional serocybene therapies that often require lengthy in-clinic sessions by reducing the duration and intensity of this psychedelic experience. CYB 003.
May make psychedelic assisted therapy more accessible and scalable in clinical settings. If successful, it could become the first FDA approved psilocybin based treatment for depression, offering a novel approach for patients who are struggling with current antidepressant options.
It's development reflects A broader shift towards precision psychiatry and innovative mental health therapies.
Next, we'll discuss a drug called OX124. It's a high dose intranasal formulation of naloxone developed to reverse opioid overdoses, particularly those caused by our potent opioid like fentanyl.
It uses Orexor's drug development platform to achieve faster absorption and higher bioavailability compared to existing naloxone products. It's designed as a rescue medication for emergency use, aiming to restore breathing and consciousness, and individuals experience opioid induced respiratory depression. It's formulation allows for rapid.
Onset of actions, which is critical in overdose situations where seconds really matter. The product is intended to be administered by non medical personnel, making it suitable for use in community settings. Despite its promising profile, OX124 has not yet received FDA approval.
Orexo submitted a new drug application in September 23, but the FDA issued a complete response letter in July 24 requesting additional technical data on the final commercial product and a human factor study to ensure safe and effective use by the layperson.
This was a second rejection in 15 months, with the FDA expressing concerns about the transition from pilot scale to commercial scale manufacturing. It remains in development and Orexo is working to address the FDA's feedback. If approved, it could become a vital tool in combating the opioid.
Crisis by offering a more potent and rapid, rapid acting alternative to current naloxone formulations.
So that's what's on the horizon. But what about the medications? We already know expanded use approvals are giving these new therapies, new roles where we'll turn to our attention now. First, what we saw was a new SETI, a long-acting injectable form of risperidone.
It just recently received FDA approval for expanded indication is now approved for maintenance treatment of bipolar one disorder in adults. This builds on its original approval for schizophrenia and marks a significant step in long-acting treatment options for serious mental illness.
Uzeti can be administered either once monthly or once every two months via sub Q injection, offering flexibility for patients and providers. The approval was supported by clinical data and model-informed drug development approaches that demonstrated Uzeti's ability to maintain mood stability in patients with bipolar one disorder.
Both as a monotherapy and adjunctive therapy with lithium or Valproic. Its PK profile allows for a rapid achievement of therapeutic blood levels, and its safety profile remains consistent with what is known about risperidone. This expanded use positions Zuzetti as a versatile and convenient option for long-term management.
For both schizophrenia and bipolar 1 disorders, potentially improving adherence and outcomes in patients that benefits from sustained release antipsychotic therapies.
Kies.
OK. Next one we will talk about is the expanded use for Capelida. It recently received FDA approval for an expanded use as an adjunctive treatment for major depressive disorder, marking a significant milestone in its clinical utility. This new ad indication adds to existing approval for.
Schizophrenia and bipolar depression, making CAPLITA the only medication currently approved to treat all three major psychiatric conditions. Schizophrenia, bipolar one and two depression, and now MDD. The approval for MDD is specifically for use in combination with antidepressants, offering a new option for.
For patients who have not received adequate relief with standard therapies alone, this expanded use is supported by clinical trial data, demonstrating CAPLITA's ability to significantly reduce depressive symptoms when added to existing antidepressant regimens with a safety profile.
Consistent with previous indications, the most common side effects reported include somnolence, dizziness, dry mouth, and weight gain, though Kaplita is generally considered to have a lower risk of metabolic complications compared to other atypical antipsychotics.
With one daily oral dosing and broad-spectrum efficacy, Kappalitis expanded approval positions itself as a versatile and convenient option for clinicians managing complex mood and psychiatric disorders. Nancy, I'm going to pass it back to you to talk about what's new with supplicate.

Mixon, Nancy   21:10
Yeah, before I get into that, we had one question about the Oozdesi and it was if it's the same sub Q injection as it always has been. That is correct. It is. It just is now approved for a wider range of uses. As far as Dublicade goes, that one is going to be your long-acting buprenor.

Yenney, Cameron R   21:21
Yep.

Mixon, Nancy   21:30
Morphine injection and recently it was approved for expanded use, which includes a rapid induction protocol. So that's going to significantly enhance its clinical flexibility for treating our opioid use disorder patients. The update's going to allow for.
A faster transition. So instead of them being stable on the medication for a full seven days, you can do a one dose of 4 milligram oral buprenorphine. Wait an hour after that, and as long as they're not precipitating withdrawal symptoms, you can inject the sublicade in.
It also allows for a second dose to be given at seven days after that first dose, which brings the patients up to that steady state a lot faster, and it allows for patients who are starting the sublicate to not necessarily need a oral for the meantime for the first couple weeks while it builds up.
Up into the system, they also have included some other sites. So where it used to only be in the abdomen, now sublicade can be injected into the thigh, the buttocks and the upper arm, which offers a greater convenience for both our clinicians and our patients.
As far as the rapid induction protocol goes, it's supported by clinical data demonstrating that it is comparable for safety and efficacy to the traditional initiation of those seven days. It does have improved treatment retention and a faster achievement of those therapeutic buprenorphine levels.
Common adverse effects remain the exact same. You're gonna have the injection site reactions, Constipation and nausea, but it will reduce our barriers to initiation and expand administration options.
Sublocate's updated label position is positioned it as a more acceptable or sorry, accessible and patient-centered solution for the long-term opioid use disorder management in our patients.
What I've seen is that with my clinic's regional assessment center, they're able to get them the buprenorphine test and inject the sublicade before they even leave their three days of, you know, withdrawal management and things like that. So it certainly is helping get these patients on it faster.
and making sure that they're more successful with staying off of opioid use or with their opioid use disorder. And then um now we have a
Poll What do you guys see as the biggest benefit of Sublicaid's expanded use for opioid use treatment, faster induction protocol, multiple administration site options, improved patient convenience or comparable safety?
And efficacy.
It looks like so far the polls coming in at about the same for faster induction protocol as well as the multiple administration sites kind of adding to that improved patient convenience, but the.
Faster induction seems to be the biggest thing.
So next we have our patient journey. This is our real world impact and it's something that we kind of have to consider. So starting in about April of last year, Genoa was allowed to do an alternate site of care for supplicate injections.
And this allowed me as a site manager to be able to inject Sublocade for my clinic, which really helped out a lot of patients in the clinic as we had some transitions between providers and there were a couple of months where.
There were, it wasn't necessarily a provider in office, it was telehealth. So it allowed me to inject for them. We had one patient who she's, you know, about a 40 year old woman. She came in, she had been at the regional assessment center and they gave her her first injection up there and I got
See her a month later at this injection. You know, she still looked a little rough, kind of like all of our substance use patients do when they're first starting their journey. And her husband was with her at that time. She was really grateful to be able to get the injection and to continue on with her pathway.
Month two and three were a little rougher for her. Mostly she came in. We had a lot of extra conversations because her husband was not going to be on that journey with her and he was using and she was really fearful for his life and couldn't understand why he didn't want to.
also try to get clean. And so just taking that extra time to really help her and talk with her and let her, you know, have her feelings about the whole situation and help her continue to stay on her journey. It was so amazing. And then at month four,
her husband came in. So he decided he needed to start on his journey too. And now there was a huge turning point for her. And just seeing her the last couple of months and having her come in, she's all smiles. She's gained like 20 lbs. She looks amazing and happy and healthy, and so does her husband. And so it's really important to kind of
consider the extra support that our patients are getting outside of just us, umm but that that's not always the case. They don't always have the supportive person to help them. And so sometimes we need to take that extra time with them and really, you know, make sure they understand
and that they are supported and that this is important to everybody involved in their care.

Yenney, Cameron R   27:40
Yeah, I I love to hear those stories of the the patients and the people behind the scripts that we received. I think it's really impactful. Nancy's doing a great job helping her clinics out injecting sublocade. But I also want to mention that we can also we just started beginning injecting.
as an alternative side of care. So if that's something that your clinic or that you could benefit from, please reach out to your local Genoa healthcare pharmacy and they might be able to help you out. Um But with that, this includes the content portion of today's presentation. We'll now open the floor to questions.

Mixon, Nancy   28:02
Yes.

Yenney, Cameron R   28:20
free to type your question in the chat and any questions that we're unable to answer today, we'll follow up on when the day's presentation is posted.

Mixon, Nancy   28:30
I did want to touch base real fast on the Brixadi alternate site of care. So it is starting this week as in Colorado as the pilot. And then next week um will be kind of expanded. And there are a couple of states that do have a little bit more of the legal background that they still have to go through.
So it might be a couple weeks out for some of those states that are a little more complicated.

Yenney, Cameron R   28:56
Right. Yep.
Someone just made a comment that he the problem he's found uh with the new Risperino and sub queue um is the size and the uh pain associated with the injection.

Mixon, Nancy   29:23
So some things you can do to kind of help with the pain is get like a topical lidocaine, prilocaine prescription for the patient. Have them put it on about an hour before, you know, tell them ahead of time, hey, we're doing the left side or the right side, whatever it is.
and then wrap it with some saran wrap and just numbing that area can help. I've also seen some providers use injectable lidocaine and giving it 15 minutes and then injecting it in this can help with that pain. Um
So those are some options that we do have. It's not necessarily, you know, the.
Manufacturer doesn't say, hey, let's do the injectable lidocaine. So you might want to look at some of the, you know, the studies and see if there's any studies that whether or not it would affect the efficacy. But I know with the like supplicate that the injectable lidocaine before doesn't have any issues.
As far as you know, helping with the pain or making it the medication not work as well, but if you're concerned, the topical can definitely work.

Yenney, Cameron R   30:49
Right. Well, Nancy, I think that's all the questions that came in. I wanted to thank you all for joining us today. It was great to see you all virtually. If you have any questions, please feel free to reach out to either myself or Nancy at the provided e-mail.
We'll be sending out the recording of this and it will be available on our website. Thanks again for joining us and have a good day. Yeah.

Mixon, Nancy   31:10
Cameron, we just got another question. Um.

Yenney, Cameron R   31:14
Oh yeah. So the difference between Narcan and the Orexor is there's a new formulation and delivery device that can offer a faster, rapid absorption of the the medication so you can get a quicker response than from the Narcan.

Mixon, Nancy   31:15
It says.

Yenney, Cameron R   31:31
Um, so it's the delivery system that how it differs in the the Narcan.

Mixon, Nancy   31:42
Is it an injection or is it like a nasal spray?

Yenney, Cameron R   31:45
It's an intranasal, same kind of as an Arcan. Like I said, it's just a different way of the the drug delivery system that gets absorbed into the system that gives it a rapid, faster onset. So I'm really thinking that it's gonna be able to provide a.
Benefit for our the big problem, the synthetic opioid fentanyl out there that the biggest hurdle right now is it's going to be used by non medical personnel, so in the community setting and so the FDA is just being very careful on getting that approved.
Before the layperson can use that in the community.
Alright, again, we'll be sending this recording out and it will be available on our website. Thanks for joining us. Any additional questions, please reach out to either myself or Nancy.