HARMONY BIOSCIENCES INITIATES PHASE 3 TRIAL OF PITOLISANT IN ADULT PATIENTS WITH IDIOPATHIC HYPERSOMNIA
Excerpt from the Press Release:
PLYMOUTH MEETING, PA, April 27, 2022— 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.
“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.”
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 U.S. ranges from 30,000 – 40,000.
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