Axsome to File NDA on Narcolepsy Drug

Axsome Therapeutics says it is planning to submit an NDA based on just-reported Phase 3 trial data on AXS-12 (reboxetine), described as a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator, for treating narcolepsy. The data showed that AXS-12 achieved the primary endpoint in the ENCORE Phase 3 trial, demonstrating a statistically significant improvement in the frequency of cataplexy attacks compared to placebo, according to the company. Regarding its safety, AXS-12 was said said to have been shown to be well tolerated during long-term dosing with a safety profile consistent with that observed in previously completed trials.

AXS-12 is thought to modulate noradrenergic activity to maintain tone during wakefulness, and noradrenergic and cortical dopamine signaling to promote wakefulness and enhance cognition, according to the company. AXS-12 was previously granted an orphan drug designation for treating narcolepsy.