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AXS-12 Phase 3 Trial Enrolls First Individual
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Axsome Therapeutics continues to explore its narcolepsy drug after the FDA granted it orphan drug designation.
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
