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Axsome to expedite plans of AXS-12 in sleep disorder, following FDA meeting

September 21, 2020

Axsome Therapeutics (NASDAQ:AXSM) says that the development plan for AXS-12 for the treatment of narcolepsy, has been expedited following a Breakthrough Therapy meeting with the FDA.

Narcolepsy is a neurological condition characterized by excessive daytime sleepiness.

The expedited development plan includes one Phase 3 efficacy trial, which, along with the previously completed Phase 2 CONCERT trial, will be used to support the filing of the marketing application for approval of AXS-12 for the treatment of cataplexy (a sudden loss of muscle tone triggered by strong emotions) in narcolepsy.

The planned Phase 3 trial will be a randomized, double-blind, placebo-controlled, parallel-group study, and the Company intends to initiate the trial in 1Q 2021. Patients completing this trial will be eligible to enroll in an open-label safety extension study.

Axsome says that certain existing, completed clinical pharmacology studies of reboxetine, previously obtained through an exclusive license from Pfizer, are considered sufficient to support an NDA filing for AXS-12.

AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor. Modulates noradrenergic activity to promote wakefulness, maintain muscle tone and enhance cognition.

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