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# Alkermes Reports Phase 2 Results for Narcolepsy Drug
- URL: https://www.fdaweb.com/alkermes-reports-phase-2-results-for-narcolepsy-drug/
- Published: 2025-11-12T12:00:00.000Z
- Updated: 2026-09-14T15:26:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160202

Alkermes says that its investigational once-daily therapy alixorexton significantly improved wakefulness and reduced daytime sleepiness in patients with narcolepsy Type 2 (NT2), meeting both primary endpoints in the company’s Vibrance-2 Phase 2 clinical trial. The company says the data highlight alixorexton — the first oral orexin 2 receptor agonist to show efficacy in a large NT2 study — as a potential first-in-class treatment for the rare neurological disorder. Alkermes said the findings, combined with positive data from its earlier Vibrance-1 trial in narcolepsy Type 1, will support the launch of a global Phase 3 program in early 2026.

In Vibrance-2, 93 adults with NT2 were randomized to receive one of three once-daily doses of alixorexton (10 mg, 14 mg, or 18 mg) or placebo for eight weeks, according to the company. The study met its dual primary endpoints, showing statistically significant and clinically meaningful improvements on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS). The 14 mg and 18 mg doses achieved statistical significance on MWT (p<0.05), while the 18 mg dose was significant on ESS (p<0.05), Alkermes adds.

Alixorexton was generally well-tolerated across all dose groups, Alkermes says, adding that most adverse events were mild to moderate, with no serious treatment-emergent adverse events or notable safety signals in laboratory or cardiac assessments. Common side effects included increased urination, insomnia, dizziness, headache, and urinary urgency. Roughly 95% of participants completed the trial and entered an ongoing open-label extension phase, it says.

Alkermes plans to present the full data from the Vibrance-2 study, including exploratory results on cognition and fatigue, at an upcoming scientific meeting.