Alkermes(US:ALKS) Prnewswire·2025-11-12 12:30Core Insights - Alkermes plc announced positive topline results from the Vibrance-2 phase 2 study, demonstrating the efficacy of alixorexton in patients with narcolepsy type 2 (NT2) [1][14] - Alixorexton met dual primary endpoints, showing statistically significant improvements in wakefulness and excessive daytime sleepiness compared to placebo [1][6] - The drug was generally well tolerated across all tested doses, with no serious treatment-emergent adverse events reported [1][6] Study Details - The Vibrance-2 study involved 93 patients with NT2, randomized to receive alixorexton (10 mg, 14 mg, or 18 mg) or placebo for eight weeks [3][9] - The primary endpoints included improvements in mean sleep latency on the Maintenance of Wakefulness Test (MWT) and reductions in scores on the Epworth Sleepiness Scale (ESS) [9] - The 14 mg and 18 mg doses of alixorexton achieved statistical significance in improving mean sleep latency, while the 18 mg dose showed significant improvement in excessive daytime sleepiness [6][9] Safety Profile - Alixorexton was well tolerated, with most treatment-emergent adverse events being mild to moderate [6][9] - Common adverse events included pollakiuria, insomnia, urinary urgency, dizziness, and headache [6][9] - Approximately 95% of participants completed the eight-week double-blind portion of the trial and continued into an optional five-week open-label extension [6][9] Future Plans - Alkermes plans to initiate a global phase 3 program for alixorexton in the first quarter of 2026 [7][11] - Detailed results from the Vibrance-2 study, including exploratory outcomes related to cognition and fatigue, will be presented at a future scientific meeting [7][11] - The company is also conducting the Vibrance-3 phase 2 study to evaluate alixorexton in adults with idiopathic hypersomnia [7][11]