Axsome’s AXS-12 achieves primary endpoint in mid-stage narcolepsy study

Axsome Therapeutics (NASDAQ:AXSM) announces 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 and improved cognitive function, sleep quality and sleep-related symptoms.

At Week 2, AXS-12 demonstrated a mean reduction of 14.6 cataplexy attacks per week compared to a reduction of 2.6 attacks per week for placebo, representing mean reductions of 48.8% and 8.6% from baseline, respectively.

The proportion of patients achieving a 50% or greater reduction in the weekly number of cataplexy attacks was 76.2% for AXS-12 compared to 30.0% for placebo at Week 2.

Axsome intends to initiate Phase 3 trials of AXS-12 in 2020.

Shares are up 6% premarket.

https://seekingalpha.com/news/3523255-axsomes-axsminus-12-achieves-primary-endpoint-in-mid-stage-narcolepsy-study-shares-up-6