All right, great. Hi. Thanks for joining us today. My name is Mark Jacobson. I'm the Chief Operating Officer at Axsome Therapeutics. Thank you to Goldman Sachs for hosting us today. I may be making forward-looking statements, and we'd invite you to review our disclosures and summary of risks and uncertainties, which you can find in our filings with the Securities and Exchange Commission. Axsome Therapeutics, our mission is to develop and deliver transformative, innovative medicines for the hundreds of millions of people living and impacted with or by central nervous system disorders. There are more than 150 million people in the United States who are impacted by the 10 serious CNS conditions that we're focused on within neuroscience. Neuroscience conditions have historically been underserved by the biopharma industry, and that is in psychiatry and neurology. Within those categories, underserved unmet needs are twofold.
One is areas of unmet need where there are none to only a few treatments approved, think Alzheimer's disease agitation in this case, to areas where there are multiple products approved, but patient outcomes are still lacking, in particular with respect to efficacy. In that case, think migraine, think depression. We are focused on a number of indications within psychiatry: major depressive disorder, MDD, Alzheimer's disease agitation, smoking cessation, ADHD, and binge eating disorder. We'll talk about the updates for those programs here. Within neurology, that's obstructive sleep apnea, migraine, narcolepsy, fibromyalgia, and shift work disorder. The way we think about delivering innovation to these areas, to patients, to HCPs, there are five pillars. One is novel mechanisms of action.
Within the areas where there are multiple products approved, we think about approaching those areas with novel mechanisms of action that deliver distinct and differentiated treatment outcomes. We think about multi-mechanistic modes of treatment, and that would be, for example, Auvelity, Symbravo, and some of the other programs in the pipeline. Through some of those multi-mechanistic approaches, we focus on metabolic pharmacokinetic modulation. Utilizing central products or product candidates that are active in the central nervous system to also modulate the metabolism of other drug substances. Clinical trial innovation. In CNS, clinical trials have historically had difficulty separating from placebo due to high placebo response rates. We work on designing trials that can detect signals if you have an active molecule. The final pillar is innovation with respect to molecular drug delivery.
Determining ways to deliver molecules that are active in the central nervous system in a way that they can result in distinct pharmacodynamic impacts. Snapshot of the company, we think we have a singular neuroscience pipeline in the industry. When you think about that, we're diversified commercially. We have three commercial products, two of which we developed in-house. We have two NDA stage programs, five late-stage programs in ongoing phase three development. All of those lead to potentially seven additional new products or indications through 2027. We've covered what we're focused on, but 10 highly prevalent or difficult to treat areas of unmet need in CNS. Here's the pipeline broken out in psychiatry and neurology, and we'll run through the updates for each program. The pipeline is such that in totality, there are $16.5 billion of potential peak sales.
Just taking Auvelity, Sunosi, and Symbravo, the potential peaks are approved products. Potential peak sales are $2 billion-$4.5 billion. Quick snapshot of the year to date and the balance of the year and what's up for 2026. Symbravo that was approved earlier this year. And then we've had a number of positive phase 3 clinical trial readouts. I will cover those. Looking ahead, regulatory and commercial side, launch of Symbravo that is imminent, and we'll look forward to sharing updates there. SNDA submission for Alzheimer's disease agitation that is on track for the third quarter. We have an NDA submission plan for AXS-12 in narcolepsy in the second half of the year. Clinical trial readouts right now, we have the ENGAGE phase 3 trial of solriamfetol in binge eating disorder.
That top line is on track for 2026, so that's enrolling through the balance of the year. Same thing with the sustained phase three trial of solriamfetol in excessive sleepiness in shift work disorder. That enrollment is ongoing and expect top line next year. We have a number of trials that we expect to start between now and the end of the year, and I'll cover those. Commercial highlights quickly. Again, three approved products. Auvelity in rapid growth phase, annualizing as of the end of the first quarter at a $400 million run rate. Dramatic growth, we expect that to continue. Sunosi, growing steadily, that is approved for excessive daytime sleepiness in narcolepsy or obstructive sleep apnea. Growing steadily, and we're pleased with how that business is going. Finally, Symbravo, as I mentioned, that is our new product for the acute treatment of migraine.
That was approved in January, and that will be launching this month. Auvelity, oral NMDA receptor antagonist. This is a dramatically new way of treating depression with oral treatment. The key thing here is it's fast and it lasts. Quick snapshot of growth in terms of scripts since launch and a couple of callouts as we're here. Right now, as of today or end of the first quarter, just north of 50% of the prescriptions are in first or second line. First line or first switch in patients. We're very pleased with that, especially at this stage of launch. About 55% of patients start Auvelity as monotherapy, and we're very pleased with that as well. Snapshot of quarterly net sales. I mentioned the annualized run rate, and we expect growth to continue at a nice clip.
That will be in the near term driven by, I think, three key drivers of growth. One is the field force expansion. We completed an expansion of 40 additional sales reps at the end of the first quarter. They are in the field. We are seeing the start of that productivity in terms of pull-through through new-to-brand scripts. We expect continued evolution in terms of covered lives in the commercial channel. That is both improvements in utilization management and increased number of lives covered. Finally, we will potentially roll out a national DTC campaign in the second half of the year. Turning to Sunosi, as I mentioned, this is our product for excessive sleepiness in OSA and narcolepsy and steady growth here. Just a real quick snapshot, moving nicely. It is a very healthy component of the business, and we would expect that growth to continue here.
In particular, we're very excited about potential efforts on the R&D side for potential label expansion. Annualizing at about a $100 million run rate, which is great, and we're pleased with how that business has been performing since we acquired the product. Symbravo, this is a novel, again, one of our pillars of growth, multi-mechanistic treatment options for oral for acute treatment of migraine. What's very interesting about Symbravo is the clinical data that we generated in a variety of migraine severities. The studies position it and allow HCPs to use this in a variety of patient profiles, early line or mild migraine pain to significant migraine pain, say, in individuals who have had inadequate response to prior oral acute treatments. It uses our Mosaic technology. This is a technology that we developed in-house to deliver meloxicam and rizatriptan. We're offline briefly. All right. Great.
Sorry for those joining online. We should now be back on slide 19. Simbravo launch readiness. The field force has been hired. They've gone through training. It's 100 reps. They will be in the field imminently, and we'll have an update for you all soon. The key thing about migraine is there are a number of treatment options, but greater than 80% of patients discontinue their acute migraine treatment within the first year. If you survey patients and clinicians, that is due to inadequate treatment on the efficacy side. Turning to the development pipeline, we have AXS-05 for Alzheimer's disease agitation. We completed that clinical program at the end of this past year. We are building an NDA submission. As I mentioned, the work is underway now.
No patients are being treated, and that submission is on track for the third quarter of this year. They have high unmet medical need and currently about 7 million adults in the US, and about 70% of them have agitation. About 7 million adults with Alzheimer's of the dementia type. This is the key symptom that leads to placement in long-term care facilities. For the clinical data that we've generated, we have three positive studies. Advance one here, that is a parallel group study of AXS-05 versus placebo and bupropion. We show here a core two. This is a randomized withdrawal design study versus placebo. Very consistent results across the studies that we generated, and we met with FDA and announced that we've been interacting with FDA throughout the development program.
The most recent update was in March, the pre-NDA FDA meeting minutes, which are our alignment to proceed with submission of the SNDA. The other program we're working on for AXS-05 is smoking cessation, and we plan to start a study in this indication this year. We'll have more to say soon. Turning to Solriamfetol, we are working on a number of additional indications for potential label expansion. This is based on KOL feedback about the activity of the molecule in a number of psychiatric conditions. We've started by prioritizing ADHD, major depressive disorder, binge eating disorder, and excessive sleepiness in shift work disorder. Starting with ADHD, we have completed one positive trial in adults so far. This is the focus trial. We read out the results earlier this year, and those are shown here on the AISRS.
The next step for the program here is initiating a pediatric trial, and we plan to do that later this year. That is what we've discussed with FDA. We would need to complete a package for the indication. Focused on major depressive disorder, we think this is very interesting. Mechanistically, solriamfetol is a DNRI, so dopamine and norepinephrine reuptake inhibitor, and mechanistically very interesting with respect to depression. We wanted to look at this in adults. In particular, we were interested if from a precision perspective, there are a subset of adults wherein the mechanism could be highly relevant. We looked at excessive sleepiness. About half of patients with major depressive disorder have excessive daytime sleepiness. With the PARADIGM trial that we conducted, we saw a signal in that patient population.
The next steps here are to launch a study, a second study in major depressive disorder with excessive sleepiness. We'll be doing that this year, starting that trial this year. Binge eating disorder, also very interesting with respect to the mechanism of solriamfetol. We are currently conducting the ENGAGE phase three trial, as I mentioned. That's enrolling. That's a parallel group trial looking at solriamfetol, 150 mg and 300 mg versus placebo, and we expect top line results next year. Rounding out the development work for solriamfetol, shift work disorder, there are about 15 million individuals in the U.S. that may have shift work disorder. Just to give a sense of the impact, about a third of individuals working in the U.S. work on an alternate shift. Highly impactful and prevalent condition. We're conducting the SUSTAIN trial.
Again, parallel group trial of solriamfetol 150 and versus placebo, 300 versus placebo. We expect results next year. Okay. Turning to AXS-12. This is reboxetine in narcolepsy. Reboxetine is a highly selective norepinephrine reuptake inhibitor. Narcolepsy orphan indication, we are focused on, so it is characterized by cataplexy and excessive daytime sleepiness, a number of other symptoms including hypnagogic hallucinations. We are starting to focus on cataplexy. NT1, that is in about 70% of individuals living with narcolepsy. We have completed the clinical program. For AXS-12, there are three trials. The results from two of those are shown here, the CONCERT trial and the SYMPHONY trial. We also have results from randomized withdrawal trial. That is the ENCORE study. We plan as a result or based on this clinical program, we are planning a new drug application submission in the second half of this year.
Finally, there's AXS-14. This is esreboxetine. So this is an S enantiomer of reboxetine and also, obviously, a norepinephrine reuptake inhibitor. This is a more potent and selective enantiomer of racemic reboxetine. We have it's highly prevalent. We're very excited about this program. About 17 million people in the US have fibromyalgia, and it's highly underserved. There are only a few products approved, and there's been very little innovation in the space and no new novel therapies or therapeutics in over 15 years. Here are the study results. We submitted an NDA based on two studies, two placebo-controlled studies. We heard back from FDA that we received a refusal to file letter from them, and we announced that this morning. It is based on the second study, which was an eight-week flexible dose design trial.
What they have asked us for is a second trial of 12 weeks in duration, and that is fixed dose. The results here are the phase three trial that was previously conducted, 12 weeks fixed dose, highly statistically significant. Both studies were positive. No comments on the prior positive results. We need to, as a next step, conduct a second 12-week fixed dose trial. We're on track to do that and start that study this year in the fourth quarter. We're excited about that and the potential for AXS-14 to offer a new treatment option to patients. I'll summarize quickly and comment on IP. IP has been a focus of the company and each program that we've launched and just a very broad patent portfolio covering our pipeline. We've got robust protection depending on the program from 2039, 2040 to 2043.
A key update, I think, for folks is with respect to Auvelity. We settled earlier this year. We announced the settlement earlier this year with the first and only first filer. For Sunosi, there are multiple first filers, and we have settled or resolved four of those. There are two first filers outstanding. We are very pleased with the state of the intellectual property portfolio. Financials of the company are strong. The key thing to take away is that we have cash resources on hand that take us to cash flow positivity. $300 million as of the end of the first quarter. I am very pleased with the financial foundation of the organization. Again, that takes us to cash flow positivity. The leadership team, we have a strong leadership team across the organization backed by a very strong board of directors.
I want to thank you all for joining us today. We will look forward to providing updates through the balance of the year. Thank you.