Axsome Therapeutics released phase 3 results with AXS-12 for patients with Narcolepsy type 1 (NT1). The primary endpoint of the study was to determine if AXS-12 (reboxetine) reduced Cataplexy attacks, after five weeks of dosing. The results were significant, in addition to an earlier phase 2 study.
- Phase 3 significantly reduced cataplexy attacks vs. placebo (p=0.018)
- Phase 2 significantly reduced cataplexy attacks vs. placebo (p=0.001)
Based on these two clinical trials, and prior clinical and non-clinical studies, Axsome plans to submit an NDA (new drug application) with approval for patients with Narcolepsy experiencing Cataplexy attacks. The gating factor will be the long-term safety data, that is still ongoing with an expected completion date by December 2024.
Weekly chart of Axsome below. Thank you for reading.
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