AXS-12 Phase 3 Trial Enrolls First Individual

Axsome Therapeutics, Inc, has enrolled its first individual in the Study Evaluating a Mechanistic Approach to Treating Narcolepsy (SYMPHONY) of its new oral norepinephrine reuptake inhibitor, AXS-12.

“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,” Herriot Tabuteau, MD, chief executive officer of Axsome, said in a statement.

“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,” Tabuteau said.

SYMPHONY is a double-blind, placebo-controlled, randomized trial with individuals who have narcolepsy.

The FDA has granted AXS-12 orphan drug designation to treat narcolepsy.

Top-line results from the study are expected in the first half of 2023.

Reference

Axsome Therapeutics initiates SYMPHONY Phase 3 Trails of AXS-12 in Narcolepsy. Yahoo! Finance. News release. September 16, 2021. Accessed September 24, 2021. https://finance.yahoo.com/news/axsome-therapeutics-initiates-symphony-phase-110000378.html