FX.co ★ Axsome Therapeutics' Phase 3 SYMPHONY Study In Narcolepsy Meets Primary Goal

Axsome Therapeutics, Inc. announced on Monday that the Phase 3 SYMPHONY study of drug candidate AXS-12 succeeded in meeting its primary goal in the treatment of narcolepsy. This disease is a neurological disorder that hampers the brain's ability to regulate sleep.

The study involved 90 patients who were either treated with AXS-12 or a placebo. Those patients administered the AXS-12 drug saw an 83 percent decrease in weekly cataplexy attacks, compared to 66% for placebo patients. Cataplexy, characterized by unanticipated, brief muscle weakness triggered by intense emotions, is one of the key symptoms of narcolepsy.

Additionally, 33 percent of patients treated with AXS-12 achieved cataplexy remission at week 5, in contrast to 9.5 percent of placebo patients.

Moreover, AXS-12 also showed significant impacts beyond its primary goal. The drug not only decreased excessive daytime sleepiness but also improved concentration, memory and reduced the overall severity of narcolepsy when compared to the placebo.