
Aculys Pharma Initiates a Phase 3 Trial of pitolisant Treating Patients with Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea Syndrome
Minato-ku, Tokyo, Japan, January 24 2023 — Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, announced the initiation of a phase 3 clinical study of pitolisant (), a histamine H3 receptor antagonist/inverse agonist in patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea syndrome (OSAS), in Japan This trial is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study (Part 1) and a subsequent multi-center, open-label, long-term extension study (Part 2) to assess the safety and efficacy of pitolisant in the Japanese patient population. ―― Additional study details can be found