Axsome to Present Positive Phase 3 AXS-05 & AXS-12 Results at AAN 2025

Axsome Therapeutics, Inc., a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, announced multiple presentations spanning its innovative, industry-leading psychiatry and neurology portfolio at the 2025 American Academy of Neurology (AAN) Annual Meeting, being held April 5-9 in San Diego, California.

Oral and poster presentations include data from the positive pivotal ACCORD-2 phase 3 trial of AXS-05 in Alzheimer’s disease (AD) agitation, accepted as a late-breaking abstract, and from the positive pivotal SYMPHONY phase 3 trial of AXS-12 in narcolepsy. Additional data being presented includes a network meta-analysis comparing the efficacy of Symbravo (AXS-07) to oral CGRPs in the acute treatment of migraine.

Details for the presentations are:

Alzheimer’s disease agitation -- Title: Efficacy and Safety of AXS-05 in Alzheimer's Disease Agitation: A Phase 3 Randomized Withdrawal Double-Blind Placebo-Controlled Study -- Oral Presentation Date and Time: Monday, April 7, 11:27 - 11:33 a.m. PT -- Poster Presentation Date and Time: Monday, April 7, 12:09 - 12:45 p.m. PT -- Session Name: Late-breaking Science 1.

Narcolepsy -- Title: AXS-12 for the Treatment of Narcolepsy: Topline Results from the phase 3 SYMPHONY Trial -- Oral Presentation Date and Time: Tuesday, April 8, 10:45 - 11 a.m. PT -- Lead Author: Michael J. Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY -- Session Name: Clinical Trials Plenary Session.

Title: CRESCENDO: Results from a Survey of Symptom Burden and Quality of Life in Patients with Narcolepsy Type 1 -- Poster Presentation Date and Time: Tuesday, April 8, 8 - 9 a.m. PT -- Lead Author: Michael J. Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY.

Migraine -- Title: Comparative Efficacy of AXS-07 vs. Gepants for Acute Treatment of Migraine: A Network Meta-Analysis --Poster Presentation Date and Time: Tuesday, April 8, 5 - 6 p.m. PT -- Lead Author: Stephanie Nahas, MD, Associate Professor of Neurology at the Thomas Jefferson University Hospitals-Jefferson Health Center, Philadelphia, PA.

Symbravo is a novel, oral, single-dose medicine approved for the acute treatment of migraine with or without aura in adults. Symbravo consists of MoSEIC meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which enables the rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID) and rizatriptan is a 5-HT1B/1D agonist. Symbravo is designed to provide rapid, enhanced, and consistent migraine pain relief, and reduced symptom recurrence. The exact mechanism of action of Symbravo in the treatment of acute migraine is unknown.

AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor under development for the treatment of Alzheimer’s disease (AD) agitation and smoking cessation. AXS-05 utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components. The dextromethorphan component of AXS-05 is an uncompetitive NMDA receptor antagonist, also known as a glutamate receptor modulator, and a sigma-1 receptor agonist. The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan and is a norepinephrine and dopamine reuptake inhibitor. AXS-05 is covered by a robust patent estate extending out to at least 2043. AXS-05 was granted US FDA Breakthrough Therapy designation for the treatment of Alzheimer’s disease agitation in June 2020.

AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for the treatment of narcolepsy. AXS-12 is thought to modulate noradrenergic activity to promote maintain tone during wakefulness, and noradrenergic and cortical dopamine signalling to promote wakefulness and enhance cognition. AXS-12 has been granted US Food and Drug Administration (FDA) Orphan Drug Designation for the treatment of narcolepsy. AXS-12 is covered by issued patents providing protection to at least 2039. AXS-12 is an investigational drug product not approved by the FDA.

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!