Therapy Areas: Central Nervous System
US FDA Grants Harmony Biosciences Breakthrough Therapy and Fast Track Designations for Pitolisant
23 May 2018 - - Plymouth Meeting, Pennsylvania-based biopharmaceutical company Harmony Biosciences, LLC has received breakthrough therapy and fast track designations for its investigational product, pitolisant, from the US Food and Drug Administration, the company said.
Breakthrough Therapy designation has been granted for pitolisant for the treatment of cataplexy in patients with narcolepsy.
Fast Track designation has been granted for the investigation of pitolisant for the treatment of excessive daytime sleepiness in patients with narcolepsy and the treatment of cataplexy in patients with narcolepsy
Pitolisant is a selective histamine H3-receptor antagonist/inverse agonist; it enhances the activity of histaminergic neurons in the brain, which function to improve a patient's wakefulness and inhibit attacks of cataplexy.
Privately-owned Harmony Biosciences' vision is to provide novel treatment options for people living with rare and orphan diseases with an emphasis on central nervous system disorders, starting with patients who live with narcolepsy.
The company is committed to advancing the understanding of narcolepsy and providing information and resources to individuals who live with, and healthcare professionals who treat patients with, narcolepsy.
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