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Alkermes Announces Positive Topline Results From Vibrance-2 Phase 2 Study of Once-Daily Alixorexton in Patients With Narcolepsy Type 2
– Alixorexton is the First Oral Orexin 2 Receptor Agonist to Demonstrate Efficacy in a Large Phase 2 Study in Patients With Narcolepsy Type 2, Supporting
About this update from Alkermes Plc
[{"type":"text","content":"\n – Alixorexton is the First Oral Orexin 2 Receptor Agonist to Demonstrate Efficacy in a Large Phase 2 Study in Patients With Narcolepsy Type 2, Supporting Advancement to Phase 3 –\n \n \n – Alixorexton Met the Study's Dual Primary Endpoints, Demonstrating Statistically Significant and Clinically Meaningful Improvements in Wakefulness and Excessive Daytime Sleepiness Compared to Placebo in Patients With Narcolepsy Type 2 –\n \n \n – Alixorexton Was Generally Well Tolerated at All Doses Tested –\n \n \n – Company to Host Investor Webcast on Wednesday, Nov. 12 at 8:30 a.m. ET –\n \n \n DUBLIN, Nov. 12, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced positive topline results from the Vibrance-2 dose-ranging phase 2 study evaluating alixorexton in patients with narcolepsy type 2 (NT2). Alixorexton, formerly referred to as ALKS 2680, is the company's novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in phase 2 development for the treatment of narcolepsy type 1 (NT1), NT2 and idiopathic hypersomnia (IH). In Vibrance-2, once-daily alixorexton met the dual primary endpoints, demonstrating statistically significant and clinically meaningful improvements from baseline compared to placebo on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) at week eight. Alixorexton was generally well tolerated at all doses tested. Results from Vibrance-2 and the previously announced Vibrance-1 phase 2 study in patients with NT1 support rapid initiation of a global phase 3 program of alixorexton in patients with NT1 and NT2.\n NT2 is a rare, chronic neurological sleep disorder that affects the brain's ability to regulate the sleep-wake cycle. NT2 is primarily characterized by excessive daytime sleepiness. The NT2 patient population is heterogeneous, with differences in symptom severity and treatment response.1 In contrast to NT1, in which orexin deficiency is well established, the pathophysiology of NT2 remains less clearly defined and is typically associated with normal orexin levels.2\n In Vibrance-2, patients with NT2 (n=93) were randomized (1:1:1:1) to receive a once-daily dose of alixorexton (10 mg, 14 mg or 18 mg) or placebo for eight weeks. Topline results include:\n \n Dual Primary Endpoints\n \n \n MWT: Alixorexton demonstrated clinically meaningful improvements from baseline in ...