Alkermes Announces Positive Topline Results From Vibrance-1 Phase 2 Study of Once-Daily Alixorexton in Patients With Narcolepsy Type 1

Core Insights - Alixorexton demonstrated clinically meaningful and statistically significant improvements in wakefulness in patients with narcolepsy type 1 compared to placebo [1][2][3] - The drug showed robust improvements in patient-reported outcomes related to disease severity, fatigue, and cognition across all doses tested [1][2] - Alixorexton was generally well tolerated, with no serious adverse events reported during the study [1][5] Study Details - The Vibrance-1 phase 2 study involved 92 patients with narcolepsy type 1, randomized to receive alixorexton at doses of 4 mg, 6 mg, or 8 mg, or placebo for six weeks [2][7] - The primary endpoint was the Maintenance of Wakefulness Test (MWT), where alixorexton showed statistically significant improvements in mean sleep latency at week six (p<0.0001) [3][9] - Secondary endpoints included the Epworth Sleepiness Scale (ESS) and weekly cataplexy rates, with significant improvements noted at the 6 mg dose (p=0.005) [9] Patient-Reported Outcomes - Alixorexton led to significant improvements in excessive daytime sleepiness (ESS) (p<0.0001), narcolepsy symptom severity (NSS) (p<0.001), cognitive complaints (BC-CCI) (p<0.0001), and fatigue (PROMIS-Fatigue) (p<0.01) [9] - The study highlighted the breadth of benefits that alixorexton may provide across multiple facets of narcolepsy, addressing persistent symptoms that disrupt daily life [2] Future Developments - Alkermes plans to present detailed results from the Vibrance-1 study at the World Sleep Congress in September 2025 [6] - The company is moving forward with a global phase 3 program for alixorexton in patients with narcolepsy type 1 based on the positive outcomes from the phase 2 study [2][6]