Harmony Biosciences Holdings, Inc. announced that its Phase 3 registrational INTUNE study evaluating the safety and efficacy of pitolisant in adult patients with idiopathic hypersomnia (IH) has completed enrollment nine months before its estimated enrollment completion date. Topline results are anticipated the fourth quarter of 2023. The INTUNE study is a double-blind, placebo-controlled, randomized withdrawal Phase 3 registrational trial in approximately 200 adult patients with IH being conducted at 58 clinical trial sites across the U.S. The primary objective is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS).

Secondary objectives include assessing the impact of pitolisant on other important symptoms of IH, such as sleep inertia and cognitive impairment. Other outcome measures include patient impression of overall change in symptoms, investigator assessment of overall disease severity, and functional status. Based on recent insurance claims data, the number of patients diagnosed with IH in the U.S. ranges from 30,000 – 40,000.

Pitolisant is marketed as WAKIX in the U.S. for the treatment of EDS or cataplexy in adult patients with narcolepsy. Pitolisant is not approved for IH and is currently being evaluated as an investigational agent in adult patients with IH.