Benzinga | Sep 16, 2021 07:05AM EDT

Axsome Therapeutics Initiates SYMPHONY Phase 3 Trial Of AXS-12 In Narcolepsy

Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, enrolled the first patient in SYMPHONY (Study Evaluating a Mechanistic Approach to Treating Narcolepsy), a Phase 3, randomized, double-blind, placebo-controlled trial of AXS-12 in patients with narcolepsy. AXS-12 is a novel, oral, potent, and highly selective norepinephrine reuptake inhibitor. Topline results from the SYMPHONY trial are anticipated in the first half of 2023.



"The advancement of AXS-12 into Phase 3 testing for narcolepsy demonstrates Axsome's commitment to developing important new medicines for patients living with serious CNS conditions," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. "Narcolepsy impairs almost every aspect of a patient's life including cognitive, psychological, social, and emotional functioning. If successfully developed, AXS-12 may address multiple symptoms of this debilitating condition."

AXS-12 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of narcolepsy.