Alkermes announced detailed positive results from its Vibrance-2 phase 2 study of alixorexton in adults with narcolepsy type 2. Once-daily alixorexton met dual primary endpoints, showing statistically significant and clinically meaningful improvements in wakefulness on the Maintenance of Wakefulness Test and reductions in excessive daytime sleepiness on the Epworth Sleepiness Scale at week eight compared to placebo. The study enrolled 93 patients, and improvements were sustained through a five-week open-label extension. Alixorexton was generally well tolerated at all doses tested, with the most common treatment-emergent adverse events being pollakiuria, insomnia, micturition urgency, dizziness, and headache. Based on these results, Alkermes has initiated a global phase 3 program evaluating alixorexton in narcolepsy type 1 and type 2.
Alkermes PlcPositive phase 2 results for alixorexton in narcolepsy type 2, meeting dual primary endpoints, and initiation of phase 3 program.