Harmony Biosciences, a pharmaceutical company dedicated to developing and commercializing therapies for patients with rare neurological diseases, announced that the FDA has accepted an investigational new drug application for pitolisant for the treatment of idiopathic hypersomnia (IH).

Harmony is planning to initiate a phase 3 clinical trial to evaluate the safety and efficacy of pitolisant in adult patients with IH in the first half of 2022.

“We are excited to announce this latest development consistent with our goal to expand the utility of pitolisant beyond narcolepsy where we hope to have an opportunity to help even more patients living with rare neurological diseases,” John Jacobs, president and chief executive officer of Harmony Biosciences, says in a statement. “Initiating a phase 3 trial in patients with IH will accelerate our clinical pipeline for pitolisant and, if successful, would potentially give us the opportunity to pursue our next new indication for WAKIX.”

IH is a rare and chronic neurological disease that is characterized by excessive daytime sleepiness (EDS) despite sufficient or even long sleep time. People living with IH experience significant EDS along with the symptoms of sleep inertia (prolonged difficulty waking up from sleep) and ‘brain fog’ (impaired cognition, attention, and alertness). Based on insurance claims data, the number of patients diagnosed with IH in the US ranges from 30,000– 40,000.

Pitolisant is marketed as WAKIX for the treatment of EDS or cataplexy in adult patients with narcolepsy. Harmony is also evaluating pitolisant for the treatment of EDS and other symptoms in patients with Prader-Willi syndrome, and for the treatment of EDS and other non-muscular symptoms in adult patients with type 1 myotonic dystrophy.