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HARMONY BIOSCIENCES INITIATES PHASE 3 TRIAL OF PITOLISANT IN ADULT PATIENTS WITH IDIOPATHIC HYPERSOMNIA
PLYMOUTH MEETING, Pa., April 27, 2022 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to
About this update from Harmony Biosciences Holdings, Inc.
[{"type":"text","content":"PLYMOUTH MEETING, Pa., April 27, 2022 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (\"Harmony\") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced the initiation of its Phase 3 trial evaluating the efficacy and safety of pitolisant in adult patients with idiopathic hypersomnia (IH), known as the INTUNE study. \n\n \n \n \n \n \n \n\n \n\"There has been much interest by both the patient community and healthcare professionals in pitolisant for the treatment of IH and we are excited about the initiation of our Phase 3 INTUNE study in adult patients with this rare neurological disorder,\" said Harmony's Chief Medical Officer, Jeffrey Dayno, M.D. \"Given the novel mechanism of action of pitolisant, which works through histamine, an important wake-promoting neurotransmitter in the brain, we are looking to translate innovative science into therapeutic possibilities that have the potential to improve the health of people living with IH.\"\nIH 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 U.S. ranges from 30,000 – 40,000.\n\"We are excited to initiate this Phase 3 trial and we are hopeful these efforts, if successful, will lead to Harmony seeking U.S. regulatory approval for the next indication for WAKIX®,\" said John C. Jacobs, President and Chief Executive Officer of Harmony Biosciences. \"Patient needs drive our team's drug development efforts and with this in mind, it is our goal to bring WAKIX forward to help the IH patient community as we have done for patients who are living with narcolepsy.\"\nThe INTUNE study is a double-blind, placebo-controlled, randomized withdrawal study in approximately 200 IH patients which will be conducted at 60 to 80 clinical trial sites across the U.S. The primary objective is to evaluate the efficacy and safety of pitolisant compared with placebo in treating EDS in adult patients with IH. Secondary objective...