Behavioral health drug trends in 2025: Mid-year check-in

Speaker 1 0:00

Deanne, hello everyone. I'm DeAnne Cornett with open minds, and I'd like to welcome you to today's webinar behavioral health, drug trends, 2025 mid year status update featuring experts from Genoa healthcare, a leading provider of pharmacy services dedicated to individuals with behavioral health and complex needs. Genoa healthcare is the largest provider of pharmacy and medication management services dedicated to individuals with behavioral health and complex needs, with pharmacies located on site within community mental health centers and other behavioral health facilities. Genoa works collaboratively with care teams to ensure medication adherence, reduce hospitalizations and improve health outcomes. Genoa integrated approach is designed to meet people where they are offering personalized care that supports recovery and wellness. Before we get started, a few housekeeping reminders. Your audio will be muted throughout today's webinar. However, we encourage you to submit any questions using the question box on the right side of your screen, we will answer those questions during the presentation when possible, and for those we don't get to we'll follow up with responses after the webinar. You may download today's slides in the handout section of your screen, and a recording of today's webinar will be available on the open minds website by Friday. Today's conversation will explore the latest trends in behavioral health medications, including prescribing patterns, medication adherence strategies and pharmacy partnerships that support whole person care. Thank you, Kim and Allie for being here today and sharing with us these insights, and I'll leave it to you.

Speaker 2 1:39

Thank you so much. Deanne, we're happy to be here. Hi everyone. My name is Allie Butler. I am a pharmacist here with Genoa healthcare, working as a pharmaceutical program manager. And with me today, I have my colleague Kim Cordova, who is also a pharmacist, acting as a director in account management with Genoa healthcare. We're very excited to be here with you today to present on some drug trends, approvals and expanded approvals, along with things in the pipeline. The first thing that we're going to be reviewing with you today is the FDA drug approval process. So just to give a refresher, because many of us have probably not reviewed this process in a while. It goes through four phases. The first phase starts out in what we reference as a pre clinical phase, and this is where drugs are tested on animals before being tested on people. At this point, the drug sponsor will submit what is referenced as an IND or investigational new drug application, and they will do this with the details of the initial testing, and they will also present a plan for testing on humans to proceed forward to the next phase after approval of this. In this information, the FDA will then release them to start doing clinical trials. There are three clinical trials that a medication has to go through. The first clinical trial typically emphasizes safety and is done in healthy populations. So this isn't the treatment for the impacted population or the impacted disease, state or condition. This is a healthy population studying solely the safety of the medication. Phase two will then emphasize effectiveness. This is where they're going to bring in that group of impacted patients with a respective disease state or condition. It's typically a couple 100 patients, and they will study effectiveness at this point, then they will transition into phase three. This is a much broader study that will include safety and efficacy of the medication. Typically, we'll see 1000s of patients in these studies, and it's used to gather more information in various populations. You'll sometimes see several phase three trials before a medication is submitted to the next step. That next step is a new drug application referenced as the NDA and the FDA will then take this new drug application and review all of the data that was submitted by that drug manufacturer. At this point, they will make a decision to either approve or disapprove. If they do approve, it will transition into what they call phase four, which is post marketing risk assessment, and this is where they continue to monitor the drugs efficacy and safety once it's been released to the public. This also is sometimes where they will pull additional research to support expanded labeling, which we will talk about in regards to other medications later on in the presentation. So this slide here is going to highlight, over the last 10 years, the approvals that have occurred within the FDA. If you look at last year, 2024 there were 50 approvals. For this year, we are now up to 19 drug approvals. This info. Information can all be found on the FDA website. The main thing to highlight here is that a medication from beginning to end, on average, takes about 15 years to go through this process. So that is why a patent is typically applied to branded medications, because it's an extensive process, and, you know, it has to make sense from a financial standpoint for that drug company in order to do a 15 year long process

Unknown Speaker 5:29

before we move

Speaker 2 5:31

on into the presentation. I just wanted to open it up to see if there were any questions regarding the FDA drug approval process.

Speaker 1 5:40

We haven't had any come through just yet, Allie, but we'll keep an eye out for them. Okay? Thank you.

Speaker 2 5:47

The rest of the presentation, we've split up into various sections. The first section, as I mentioned, is going to be drug approvals, with the first medication being or zaffrey, this is a once monthly long acting injection for the treatment of schizophrenia and as an adjunct to mood stabilizers or antidepressants for schizoaffective disorder in adults. This is the second long acting injectable paloperidone palmitate to receive FDA approval in Vegas, sustaina being the first, and this approval was done based off of the results of an open label randomized multiple dose study, trial that enrolled 281 participants, ages 18 to 65 with Schizophrenia or Schizoaffective Disorder. And the study was designed to evaluate the PK the pharmacokinetic profile of ers offering and compare it to in Vegas, system free was demonstrated to be bio equivalent at steady state after multiple injections, and when compared with in Vegas, system or software's initial dosing was optimized by omitting the injection on day eight after the first injection, and this did result in a comparable total drug exposure. The safety profile was consistent with that which we know for in Vegas, sustaina and then the most common adverse reactions were injection site reaction, sedation, dizziness, Apatheia and EPS disorder. So just to highlight the main difference between the two products, or zafri and Invega, is the way that we initiate with Invega, you inject on day one and then you inject again on day eight, whereas with our zafri, you can start your injection on day one and continue with maintenance thereafter. So it just gives you another option with a little more flexibility in prescribing practices. The next medication we're going to be discussing is Coben fee. This was formerly known as car XT, and is indicated for the treatment of schizophrenia. It was approved last September and launched in October, and it's the twice daily oral medication with a novel mechanism of action. It combines two different medications. So the first is anomaly, which is a muscarinic m1 and m4 receptor agonist, which penetrates CNS to stimulate receptors in the brain. And then trosium, which is probably more familiar as a treatment for overactive bladder. This is a non selective muscarinic antagonists, and it does not cross the CNS. So this one will reduce peripheral cholinergic side effects that are associated with sonomaline. So seeing the combination of those two medications is a novel mechanism of action. This approval was based off of data from emergent trials that looked at safety and efficacy across multiple studies. Emergent four and five were phase three open label trials, and they looked at over 700 participants who received at least one dose, and 134 of those participants who completed an entire year of treatment. The data indicated drug was generally well tolerated, with no significant changes in prolactin or movement disorder scale scores. And the interesting thing with this medication is that some patients saw stabilization or improvement in key metabolic parameters, so weight, total cholesterol, triglycerides, a 1c the most common adverse event was mild or moderate and included GI distress or GI issues. There were some other adverse events, including dry mouth, dizziness and hypertension. And this medication does come with a warning. It can cause urinary retention, increased heart rate, decreased gastric movement and or angioedema of the face and lips. It is not recommended for patients with mild hepatic impairment or severe renal impairment. So this approval was very exciting. We've had no new treatments for schizophrenia approved in. Nearly three decades, and one of the major concerns with most of our behavioral health medications are related to metabolic concerns, so adding a drug option that has a favorable profile related to these parameters can potentially change the CO morbidity profiles that we often see with these classes of medication and the conditions themselves. So we will see other drug companies start to target m1 and m4 receptors, and there are a couple of other clinical trials already in progress. Next medication we're going to be detailing isn't necessarily a specific to behavioral health, it is an acute pain medication. So we wanted to discuss a couple of medications that are relevant, because we often see pain syndromes in combination with behavioral health issues. Chernovacs was a medication that was approved in January for the treatment of moderate to severe acute pain, and this is the first new class of medication to treat acute pain in over 20 years. This medication blocks sodium channels and nerves, blocking pain signals before they reach the brain. It inhibits those sodium channels in peripheral nerves and obstructs those channels, making it harder for the cells to transmit pain sensations. But because it's only acting in the peripheral nerves. It doesn't carry the same potential for addiction that's associated with opioids. So it's a non opioid treatment for acute pain, which can definitely change the landscape of how we treat acute pain issues. It has been limited to only acute pain, so not the much larger issue of chronic pain but as we see this class of medication develop, and additional research being done with this medication and just this mechanism of action, I suspect we will start to see some developments with chronic pain treatment in this same category as well. The last medication for expanded approval is yet Sugo. So this medication, again, is not behavioral health specific. It's an HIV prep medication. Within the behavioral health population, we have a high percentage that are impacted by HIV, so having a prep medication that we can utilize in this population is helpful. This one is it was just approved, I think a month ago, yeah, June 18. And it is a twice a year injection for PrEP. This one also has a different mechanism of action from what we're used to. So it directly binds to the interface between capsid protein P 24 sub units in hexamers, and inhibits HIV, one replication in multiple steps of the viral life cycle that includes capsid mediated nuclear uptake of HIV, one proviral DNA by blocking nuclear import proteins that bind to the capsid and make up the virus shell. So the reason why I detail this mechanism of action is because with our other antivirals, they act only on one stage of viral replication, whereas Lena capovir is inhibiting HIV at multiple stages. This approval for this medication was based off of a trial that was published last year, and it detailed that it was nearly 100% effective in prevention of HIV, while also proving superior to once daily oral medications like Truvada. And it makes sense when we think about some of the adherence issues that are sometimes associated with an daily oral medication. The trials were double blinded, randomized, controlled trials that compared sub q lenocapivir every 26 weeks with daily oral emtricitabine, tenofovir, disoproxil fumarate or emtricitabine, tenofovir, alafenamide, most common adverse reactions were injection site reactions, headache and nausea, and just thinking about the thought process with long acting injective because that's essentially what this is, long acting injectables, especially in this space where we think of antipsychotics, and when we think about the change that it has made in treatment for some of our behavioral health conditions, those same impacts apply to all areas of treatment. So having another long acting injectable for prevention, it will help with adherence, it will also be a quality of life improve for those patients that maybe don't want to take a daily oral medication. So definitely interesting to see this develop. And I think at this point, they're now in phase one trials to look at a once yearly option as well. So our eyes posted, and hopefully do another. Update with something along that line, and before I do this section with expanded use, are there any questions on the drug approvals that we've already discussed?

Speaker 3 15:13

We haven't had any questions thus far. Ali, we encourage everyone to enter them in the chat

Unknown Speaker 15:19

if we have any questions that come up.

Speaker 2 15:23

So this next section we're going to be discussing is expanded use approvals. So these are medications that have already been approved by the FDA, but have some sort of labeling change or revision to packaging. Insert that we wanted to highlight. The first medication is spravato. This medication was indicated for treatment resistant depression concomitant with another therapy, or for major depressive disorder with suicidal ideation. In January, the vacation was approved by the FDA to be utilized as monotherapy for treatment resistant depression, and this is the first and only medication in this category. So very exciting to see this update. This was done so after a phase four study that evaluated efficacy and safety, along with tolerability of spravato mono therapy, and the study showed a rapid change in the Montgomery asperg Depression rating scale total score as early as 24 hours after the first bravado dose monotherapy and sustained through at least four weeks of treatment. Safety profile was similar to that of the combination treatment, and as I said, this approval occurred in January. It's very exciting as we think about the flexibility it provides to providers. So polypharmacy is an issue in behavioral health, and a lot of people think about polypharmacy is maybe associated with the same class, or duplication within the same class, but polypharmacy can also mean multiple medications. Five is kind of the magic number I think about when I think about the term polypharmacy, and within the behavioral health population, it is very common to see people on five medications or more, not necessarily just for that behavioral health condition, but for the CO morbidities that typically go along with it as well. So anytime we provide more flexibility in de escalation, it is a benefit to the consumer, so that secondary medication that they were on may have just been a medication they were on, because that's what insurance required in order for them to continue that to access that medication, so it will potentially remove an unnecessary medication, decrease side effects potentially impact finances if they're paying co pays on one additional medication. So exciting to see that update. The next medication we're reviewing is Abilify, maintain a and Abilify asthma, Tuffy. This medication is a treatment for schizophrenia in adults, or for maintenance monotherapy treatment of bipolar one disorder in adults. This is a long acting injectable that has been approved for many years. However, there was an update to the dosage guide that was made in March of 2025 that allows for what we reference as rapid initiation of Abilify maintenance. And this is set up so they will essentially have two separate im injections of the 400 milligram dose at two different im sites, and then a single dose of oral arapipers, all 20 milligrams, and this is all given on the first day of treatment. Previous guidelines involved a single injection followed by a 14 day overlap with oro aripiprazole. This new initiation allows for the ability to achieve therapeutic concentrations more rapidly. The asthma Tuffy two month formulation follows a similar approach. So you'll give the 960 milligram dose in the gluteal muscle, along with one injection of the 400 milligram dose in a separate gluteal or delta muscle, along with that oral dose of 20 milligram aripiprazole On the first day of treatment. So this change just adds another option for initiation. They didn't remove the other recommended initiation strategy. You now have different options for how you initiate this medication. The last medication we're going to be talking about in expanded approvals is sublocade. This medication is used for treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of transmucosal buprenorphine, or who are already being treated with buprenorphine, this treatment approach should be done as a complete treatment program that coincides with counseling and psychosocial support. So in February, they updated the package insert to allow again for what we would call maybe a more rapid initiation kind of the same terminology that we use with a previous medication. So a second injection of sublocade can be administered as early as one week after the first injection. This is different than the previous recommendation, which recommended that second dose at the four week point. There was also an update that allows for an increase in the maintenance dose from 100 milligrams to 300 milligrams, and that's for any patients where that benefit outweighs the risk. So the intent is to try to get to steady state quicker. And this, I think when, when I try to determine what type of population that this may fit into. So this could be for someone that maybe had an overdose, or someone who's on a really high dose of fentanyl, where we might use this more rapid initiation to get to steady state sooner, before I transition over to Kim to discuss pipeline medications. Are there any questions on any of the approvals or expanded approvals?

Unknown Speaker 21:13

No questions so far. Allie,

Unknown Speaker 21:17

okay, thank you, Kim. I'll hand it over to you.

Speaker 4 21:20

Thanks, Allie. It's really exciting. Of all of these things, you know, I'm acutely aware of, however, it just every time I see them. It's great to see that continued progress and that we're continuing to there. The industry continues to try to find more treatments, to give more flexibility to patients and providers. And so it's really exciting and great to be a part be a part of. And so appreciate that insight. And we'll see some common themes as I go through some products that are still currently in the study phase and not approved yet. The first medication on the radar today is BPL 003, mebufodin by Beckley Sci Tech. It's an intranasal formulation that is administered as a single dose. Currently just finished up a phase two study that had about 200 patients with moderate to severe treatment resistant depression across 38 states and six countries, including the US. So that phase two study successfully met its primary and secondary endpoints, and at this point there is a follow up open label extension study that is ongoing. Data from that open label extension is expense expected to be shared this quarter. So really looking forward to what that data shows in further insights related to safety, tolerability, and then potentially some repeat dosing. Maybe there is safety considerations with an additional dose beyond that single dose, but if we're seeing efficacy with even just one single dose, that's really exciting as well. So looking forward to hearing more updates as that product continues to be studied. And as mentioned from Allie, we had spravato in the first product that was FDA approved, related to treatment resistant depression, but clearly an area of need as we continue to develop additional treatments. And next, we have NBI. 1117568,

Unknown Speaker 23:23

also known as NBI 568,

Speaker 4 23:26

by neurocrine, and it is an oral muscarinic and for selective agonists, as you may recall, we had COVID fee that was recently approved, and a little bit of the m1 and m force. So this one's a little bit different in that it's selective for the m4 receptor and also a once daily oral treatment. It's currently being studied for schizophrenia, where there were some positive results in the phase two studies. Phase three is currently in development, again, as I mentioned, exciting product in the treatment realm of schizophrenia in that it's once daily different mechanism of action than any products that are currently on the market, similar to Coben fee, but a little bit different to that one. It's still in early stages, but as Ali mentioned, it's great to have another alternative medication with that alternative mechanism of action, because that lends to a different side effect profile, which, as mentioned, contributes to a significant amount of polypharmacy, as well as impact to quality of life as well. So really great to see that there are some other products continuing to be studied with different mechanisms of action. Next we have middle mephetamine, also known as MDMA, much easier to say that one has a more recent update in that the FDA actually issued a complete response letter to Lycos, the manufacturer that had submitted the new drug application for this product, stating that it couldn't be approved for treatment. Based upon the data that was submitted, it was suggested that additional studies be done to expand on efficacy and safety. Many experts in the field still see promise with MDMA and the VA actually received funding to evaluate and an MDMA assisted treatment option for veterans with PTSD and alcohol use disorder, still very much in early stages. I think the funding was granted in December, still kind of working toward the planning, but really looking forward to seeing the data that comes out of that trial as there's still significant opportunity. And one thing I wanted to point out, when we say MDMA assisted, that would mean that utilizing MDMA along with psychosocial treatment, so utilizing therapy in combination with MDMA for treatment. So looking forward to what that brings as well. We have a couple medications that are also in the pipeline, being studied by Indivior, indv 6001 and indv 2000 the 6001 is in phase two, similar to what is already on the market. As we mentioned, there was a change in the initiation recommendations in that second initiation dose can come sooner than originally what was approved. They're also looking at evaluating an additional treatment locations for administration, so evaluating other physical locations around the body where that treatment can be administered as well. Indv, 2000 is a new product being studied for opioid use disorder, and this is significant in that it's a non opioid treatment for opioid use disorder. So currently, most products on the market are opioid derivatives. So this will be something that's a little bit different. Also, it is orally administered. And so I imagine many of you are familiar that most of the medications are at this point. What's popular, so to speak, is the injectables. But exciting to have something that's non opioid and oral as an additional option, as there are still some barriers to treatment when it comes to injectables as well. So really exciting to see what comes of that, and will take some time for us to get a little bit more data, and it's still in the phase two area. However,

Unknown Speaker 27:31

again, something to keep an eye on,

Speaker 4 27:35

and before I go ahead and look at sharing some information about some medications that are in the pipeline for expanded use approvals. Did we have any additional questions pop

Unknown Speaker 27:45

into the chat,

Unknown Speaker 27:47

no questions at this time. Kim,

Unknown Speaker 27:50

so first up, we have caplita

Speaker 4 27:52

Luma to Perron, currently indicated for bipolar disorder and schizophrenia intracellular therapies. Is the manufacturer of this product. They had completed some positive phase three trials assessing cap light as an adjunctive therapy option for major depressive disorder. Included a double blind completed placebo controlled trial that was completed with patients who had an inadequate response to one to two courses of antidepressant therapy. This is probably something that is all too familiar to all of the providers that we have on the call today. So again, looking forward to having another option that is approved for patients in that situation. In those studies, we saw a reduction in the magist score and the treatment group higher reduction than what occurred in the placebo group as well. So a supplemental new drug application was submitted by intracellular therapies in December of 2024 at this point that is still under review. In January, Johnson and Johnson completed the acquisition of intracellular therapies, very familiar manufacture that we have in this space. And in July, just earlier this month, Johnson and Johnson submitted another supplemental new drug application with data demonstrating significant schizophrenia relapse prevention compared to placebo for caplita Then, and as mentioned, that was only just submitted in July, and so we are seeing a little bit of a delay in that process for these supplemental new drug approvals. There has been some changes with the new administration, and seeing that variance in the approval process, I think we've gotten a few updates this week alone where there have been those complete response letters that I had mentioned for a couple therapies on the market or looking to come to market. So that'll be probably a theme that we'll continue to see. Which is great. I'm glad that the data is being reviewed and significantly reviewed, because we want to have those options that. Have proven safety and efficacy before we go ahead and bring those to patients, but looking forward to those cap light expanded use approvals coming up soon, and next we have Rick salty or Brexit peprazol, currently on the market under Otsuka and Lundbeck. It's currently approved for schizophrenia, major depressive disorder and agitation associated with dementia due to Alzheimer's disease, there was a supplemental new drug application that was submitted to review the use of rexalty with sertraline for the treatment of PTSD. Unfortunately, actually, just this week, the FDA and FDA panel rejected the application. The committee felt that the efficacy wasn't established for Rexel tees treatment for PTSD. So we'll continue to see what happens with that product. But as mentioned before, we still have some other products that are continuing to be studied for the treatment of PTSD as well. Then, before we move on to what's new in psychology psychiatry, I'll pass it back to Allie. Just wanted to check in and see if there were any questions.

Unknown Speaker 31:16

No questions at this time, all right. Well, thank

Speaker 4 31:19

you, and I'll hand it back over to Allie to provide some additional updates.

Speaker 2 31:24

Thanks, Kim. It's interesting to see how challenging it seems to be to get a medication approved in the PTSD realm. My husband and I talk about this a lot. We're both veterans, and we have a lot of friends that are suffering from PTSD and MDMA has been a huge topic of conversation amongst that group. We've got friends that actually go down to Mexico to access treatments for MDMA therapies due to the impacts that they're having, so it'll be interesting to see just where this landscape goes in the realm of PTSD, and it's exciting to see some of the research that's being done in a condition that's very challenging to treat.

Speaker 4 32:12

It's challenging condition and challenging regulatory hurdles. And for good reason, but certainly hurdles that must be crossed.

Speaker 2 32:21

Yeah, absolutely. This next section that we're going to be digging into, it isn't focused necessarily on a specific medication approval or submission, but rather areas that I wanted to highlight that may be worth monitoring in the upcoming years as new developments emerge, the first being alcohol use disorder. So I am sure everyone here is familiar with GLP ones in regards to diabetes and weight management, this class of medication has blown up. It's being used for other other conditions, like sleep apnea. It's got heart protective kidney protective effects. It's just been a really unique medication, and within behavioral health, it is also now being studied for alcohol use disorder associated with the reduction in cravings. So the they recently did a phase two double blind, randomized, parallel arm trial. It was a nine week outpatient treatment. It was only 48 patients, but the primary outcome was looking at the effects of once weekly subcutaneous semaglutide on alcohol consumption and craving in adults. And then the secondary outcome was prospective changes in alcohol consumption and craving. So the initial dose, or the sorry, the initial findings for low dose semaglutide indicated that it can reduce craving and some drinking outcomes. So it definitely justifies a larger trial. And again, this is an injectable. It's not a oral medication that has to necessarily be taken on a daily basis. We have weekly injections, and there are also GLP ones being studied currently as monthly injectables. So again, looking at the potential for another long acting injectable in a different space and with alcohol use disorder, when I was doing chronic medication management, it was very challenging to find therapies that would suffice for people that were dealing with this condition, especially in populations where maybe opioid use was or opioid use was concomitant. So Naltrexone is probably the main therapy that a lot of us think about when we think about alcohol use disorder, but we can't use that with those that are on opioids. So bringing in a potentially new class of medication to treat alcohol use disorder just broadens the opportunities that will. Be available in prescribing to treat this condition. The next thing I wanted to detail is Clozapine, so many of you are familiar with the fact that the FDA removed the REMS requirements in March, just to kind of review the process of why and what that means going forward, I felt that it was an important, important point to touch on. So the REMS program was very intensive. It required frequent neutrophil monitoring in order to dispense the medication. The FDA reviewed the program and determined that it didn't measurably mitigate the risk of neutropenia beyond what labeling alone could accomplish, and in the opposite it actually placed additional requirements on patients, clinics and pharmacies that resulted in under utilization of the medication, so they removed it from rems program completely, while clinicians are still encouraged to complete the monitoring according to prescribing information, it's no longer a requirement for dispensing, and this removal allows for increased access and just removes one more barrier to improved adherence in this population. Thinking about when I was in a dispensing role, Clozapine was very hard to dispense, and it was often penalizing patients that didn't do anything wrong for, you know, an error that was not necessarily on their part. So a lab may have been lost, or maybe it was delayed in reporting, and one day late could then mean they not only do they not get their medication right away, but then it switches them to a different frequency from monitoring, and it was just very cumbersome and not in support of good consumer care. So the removal from the REMS program has definitely resulted in increased access, reduced barriers, and then improving adherence overall. So excited to see that removal, but just highlight you you still want to do that monitoring, regardless of those requirements. And then the last thing we're going to touch base on today something that I found interesting in is related to migraines with CO morbid depression. So depression, we often see that in patients who suffer from migraines. However, single agent treatments like amitriptyline or Venla vaccine have been limited. However, a unite study was conducted from 2000 to 2000 2020 to 2022 and it is studying Freeman isumab versus placebo. So this was a double blind placebo controlled randomized trial of 353 patients with episodic or chronic migraines who also have active depression. And these patients were randomized in a one to one to receive monthly freeminizumab or matched placebo. The primary endpoint was the mean change from baseline and monthly migraine days during the 12 week period, with a secondary outcome in the mean change from baseline and the Hamilton depression score treatment with freemanizumab did result in significant reductions in monthly migraine days and depressive symptoms. So this is a completely different category of medication than what we have currently as a single agent treatment for both conditions. Freeman isumab is already approved for migraine treatment, but having this additional indication potentially attached again will be in that same line with polypharmacy that we talked about previously, and potentially reduce the amount of medications that we have to utilize in order to treat multiple conditions in the same patient. So very exciting to see, and hopefully we'll see more on that. So this concludes the content portion of our presentation today. We did want to open up the floor to some questions. If you do have any questions, you can place them in the chat, and we'll be happy to answer.

Speaker 1 39:18

We do have a couple questions we can ask today, we'll continue to look at the chat and see if we have any others come in. Our first question is, what has the utilization of COVID fee looked like since launch?

Speaker 2 39:34

Kim, I can take that question. Yeah. So we we've seen good utilization. We also have a clinical team of pharmacists that will engage on clinical questions with patients or consumers that are currently utilizing that therapy and feedback has been positive on that addition, it is resolving issues for patients that were on for. Previous therapies that we're not having success with those therapies. So seeing an additional option in that space has definitely been positive, and I imagine we will continue to see increasing utilization as the medication you know, becomes more popular and more well known in the prescribing arena.

Speaker 1 40:22

Thank you, Allie, we ask that anyone submitting a question does so to the entire audience, so we'll be able to see that question when it's submitted. The next question we have is, have you seen any changes in prescribing practices with the expanded spravato labeling?

Speaker 2 40:38

I will take that one too. Actually, spravato has been interesting. To say the least. We've definitely seen an increase in utilization. And more interestingly, at least from my perspective, are the types of clinics that we're also starting to see engage. So previously, speaking, ketamine clinics were not clinics that we necessarily supported through partnership, just because they're you know, ketamine is not sourced from Genoa. We can't dispense out ketamine, but we can dispense out spravato With that expanded label. We've had a couple ketamine clinics reach out and ask questions about expanding their own offerings to include spravato. So that has been an interesting sector that I didn't necessarily foresee or anticipate developing, but certainly an area of opportunity in the behavioral health space.

Speaker 1 41:36

Thank you, Allie. And the last question we've had come in so far is we already have many treatments for schizophrenia. Do you think there is room for more? 

Speaker 4 41:46

want to get in on this answering. Allie, I'll take this one. I think the answer is resounding yes. I given the side effect profile. I mean, and really over the years, ever since, like, you know, the 50s, when first schizophrenia treatments were brought to market, there has been continued improvement in the treatment, right, making sure that we treat the effects, but also finding that balance with side effects. And so there's still significant opportunity to find ways to treat both positive, negative both symptoms of schizophrenia, as well as reduce the side effect profile that's related to the different mechanisms that are used to treat so definitely think that there's still room. And really, even as we were talking about COVID, there was a lot of excitement from patients and providers to have something different. And even though, as I mentioned, we've had a lot of progress over the years, including the injectables, which have been a very exciting development, and how those continue to refine and improve, having different mechanisms of action, similarly, there's a lot of opportunity.

Speaker 2 42:59

Yeah, I agree. I think it increases the ability of a clinician to individualize medicine when they have more options. So that's always been a goal. One size does not fit all.

Speaker 1 43:12

Great. Thank you both for your time and insight. Today, I don't see any other questions that have come in. So thank you for joining us for today's webinar on behavioral health drug trends, 2025, mid year status update. We hope the insights shared today help inform your organization strategy for medication management and integrated care planning. As a reminder, the slides and recording will be available Friday on the Open Minds website and to learn more about upcoming Open Minds education events, including sessions on medication management and strategic partnerships. Visit our events page@openminds.com

Unknown Speaker 43:51

thank you. Have a good day.