Axsome Therapeutics' Phase 3 SYMPHONY Study In Narcolepsy Meets Primary Goal

(RTTNews) - Axsome Therapeutics, Inc. (AXSM) Monday said the Phase 3 SYMPHONY study of its drug candidate AXS-12 for the treatment of narcolepsy met its primary goal. Narcolepsy is a brain and nervous system disorder that affects one's ability to regulate sleep.

In the study, 90 patients were randomized to treat with either AXS-12 or placebo. In patients treated with AXS-12, 83 percent reduction in weekly cataplexy attacks was observed, compared with 66% for placebo, achieving the primary endpoint. Cataplexy is one of the main symptoms of narcolepsy characterized by sudden and brief muscle weakness triggered by strong emotions.

Further, Remission of cataplexy was achieved at week 5 by 33% of AXS-12 treated patients compared to 9.5% of placebo patients.

Additionally, AXS-12 statistically significantly reduced excessive daytime sleepiness, improved concentration and memory, and reduced overall severity of narcolepsy compared to placebo.