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Alkermes Eyes Global Phase 3 Trial After Encouraging Data From Sleep Disorder Study
Benzinga· 2025-11-12 17:46
Core Insights - Alkermes plc announced positive topline results from the Vibrance-2 phase 2 study for alixorexton in narcolepsy type 2, showing significant improvements in excessive daytime sleepiness and sleep latency compared to placebo [1][2][4] Group 1: Study Results - Alixorexton met dual primary endpoints, showing statistically significant improvements on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) at week eight [2] - The 14 mg and 18 mg doses of alixorexton achieved statistical significance in mean sleep latency improvements compared to placebo [3] - The 18 mg dose also showed statistically significant improvements in excessive daytime sleepiness on the ESS at week eight [4] Group 2: Safety and Tolerability - Alixorexton was generally well tolerated across all doses during the eight-week treatment period, with most treatment-emergent adverse events (TEAEs) being mild to moderate [4] Group 3: Future Plans - Results from Vibrance-2 and the previous Vibrance-1 study support the initiation of a global phase 3 program for alixorexton in patients with narcolepsy type 1 and type 2, planned to start in Q1 2026 [5] - Detailed results, including exploratory patient-reported outcomes related to cognition and fatigue, will be presented at a future scientific meeting [5] Group 4: Ongoing Studies - The Vibrance-3 phase 2 study evaluating alixorexton in adults with idiopathic hypersomnia is currently enrolling [6]