Core Insights - Alkermes plc has initiated the Vibrance-3 phase 2 clinical study to evaluate the safety and efficacy of ALKS 2680 in adults with idiopathic hypersomnia (IH) [1][2] - ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist aimed at treating chronic neurological disorders characterized by excessive daytime sleepiness [1][4] - The study aims to address the high unmet need for treatment options in the IH community, as over 90% of surveyed patients reported significant impacts on their lives due to IH symptoms [2][5] Company Overview - Alkermes plc is a global biopharmaceutical company focused on developing innovative medicines in neuroscience, with a portfolio that includes treatments for alcohol and opioid dependence, schizophrenia, and bipolar I disorder [6] - The company is headquartered in Ireland and has additional facilities in Massachusetts and Ohio [6] Clinical Study Details - The Vibrance-3 study is a randomized, double-blind, placebo-controlled trial involving approximately 96 patients across the U.S., Australia, and Europe [2][3] - Participants will receive one of three doses of ALKS 2680 (10 mg, 14 mg, or 18 mg) or a placebo once daily for eight weeks, with primary and secondary endpoints focused on sleepiness reduction and adverse events [2][3] Background on Idiopathic Hypersomnia - Idiopathic hypersomnia is a rare neurological disorder affecting an estimated 40,000 people in America, characterized by excessive daytime sleepiness despite normal sleep durations [5] - Common symptoms include severe sleep inertia, unrefreshing naps, fatigue, and cognitive dysfunction [5]
Alkermes Announces Initiation of Vibrance-3 Phase 2 Study Evaluating ALKS 2680 for the Treatment of Idiopathic Hypersomnia