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Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in CONCERT Phase 2 Trial in Narcolepsy

December 6th, 2019

Axsome Therapeutics, Inc. announced that AXS-12 (reboxetine) met the prespecified primary endpoint and significantly reduced the number of cataplexy attacks as compared to placebo in patients with narcolepsy in the CONCERT Phase 2 trial. AXS-12 also significantly reduced excessive daytime sleepiness (EDS), and improved cognitive function, sleep quality, and sleep-related symptoms. AXS-12 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. CONCERT was a Phase 2, randomized, double-blind, placebo-controlled, crossover, multicenter, U.S. trial in which 21 patients with a diagnosis of narcolepsy with cataplexy were all treated with orally administered AXS-12 for 2 weeks, and with placebo for 2 weeks, with the treatment periods separated by 1 week of down-titration and washout.

Plans will now proceed into Phase 3 with AXS-12 which may one day offer patients a therapeutic alternative that can be efficacious across multiple symptoms while also having an acceptable safety and tolerability profile.

To read the entire announcement by Axsome, see link from Axsome Therapeutics.

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Date Created: December 6th, 2019
Last Updated: December 6th, 2019