Harmony Biosciences Receives FDA Refusal To File Letter For Pitolisant In Idiopathic Hypersomnia

(RTTNews) - Harmony Biosciences Holdings, Inc. (HRMY) Wednesday said that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for pitolisant for the treatment of excessive daytime sleepiness in adults with idiopathic hypersomnia (IH).

Harmony Biosciences' M.D., President and CEO said that the company is on track to initiate a Phase 3 registrational trial of Pitolisant HD, an enhanced and higher-dose formulation, in IH in the fourth quarter of 2025, with a target PDUFA date in 2028.

Pitolisant is marketed as WAKIX in the U.S. for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy, and for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy.