Axsome Therapeutics, a biopharmaceutical company specializing in central nervous system disorders, has announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) supporting an NDA submission for AXS-12 in the treatment of narcolepsy. AXS-12, a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator, is being developed to address cataplexy in narcolepsy patients.
The company's regulatory data package has been deemed sufficient for the submission of an NDA for AXS-12, and the anticipated completion of the NDA submission is set for January 2026. If approved, AXS-12 has been granted orphan drug designation for the treatment of narcolepsy, entitling Axsome to a period of seven years of marketing exclusivity in the U.S. upon FDA approval.
Narcolepsy is characterized by excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep. Cataplexy, experienced by an estimated 70% of narcolepsy patients, involves a sudden reduction or loss of muscle tone while awake, often triggered by strong emotions.
AXS-12's clinical development program in narcolepsy comprises three controlled efficacy trials and a completed long-term safety trial. The drug is thought to modulate noradrenergic activity to promote wakefulness and cognition. It has also been granted FDA orphan drug designation for the treatment of narcolepsy and is covered by issued patents providing protection until at least 2039.
Axsome Therapeutics prides itself on delivering scientific breakthroughs by identifying critical gaps in care and developing differentiated products with a focus on novel mechanisms of action. The company's portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, with multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. As a result of these announcements, the company's shares have moved 3.91% on the market, and are now trading at a price of $152.75. Check out the company's full 8-K submission here.
