Harmony Biosciences Holdings, Inc. Publishes Pitolisant Efficacy Data In CNS Drugs
December 13, 2021 at 08:05 am
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Harmony Biosciences Holdings, Inc. announced publication of a data analysis in the December issue of CNS Drugs that evaluates time to onset of response to pitolisant for excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy. The publication, Time to Onset of Response to Pitolisant for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients with Narcolepsy: An Analysis of Randomized Placebo-Controlled Trials, is also available to view online. The post-hoc analysis evaluates data from HARMONY 1 and HARMONY CTP, two randomized, double-blind, 7-week or 8-week clinical trials of pitolisant where patients were titrated to a potential maximum dose of 35.6 mg/day. Efficacy was assessed by the Epworth Sleepiness Scale (ESS) and weekly rate of cataplexy. Onset of response was defined as the first timepoint of statistical difference between pitolisant and placebo. This post-hoc analysis included 61 patients from HARMONY 1 (pitolisant, n=31; placebo, n=30) and 105 patients from HARMONY CTP (pitolisant, n=54; placebo, n=51). Onset of response began at week two for HARMONY 1 and week three for HARMONY CTP for the mean change in ESS score. A significantly greater mean change in weekly rate of cataplexy was observed at week two for HARMONY CTP and week five for HARMONY 1 with further improvement observed in pitolisant-treated patients through the end of treatment. The percentage of treatment responders was significantly greater with pitolisant versus placebo beginning at week three for EDS (defined as an ESS score reduction = 3) and week two for cataplexy (defined as a = 50% reduction in weekly rate of cataplexy [HARMONY CTP]). Onset of response for EDS and/or cataplexy was generally observed within the first 23 weeks of pitolisant treatment in adult patients with narcolepsy.
Harmony Biosciences Holdings, Inc. is a commercial-stage pharmaceutical company. The Company is focused on developing and commercializing therapies for patients living with rare neurological diseases as well as patients living with other neurological diseases who have unmet medical needs. Its product, WAKIX (pitolisant), is a first-in-class molecule with a novel mechanism of action (MOA) designed to enhance histamine signaling in the brain by binding to H3 receptors. Its WAKIX is developed for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy and treatment of cataplexy in adult patients with narcolepsy. Its narcolepsy treatment works primarily through histamine, a wake-promoting neurotransmitter. It also provides HBS-102, an investigational compound, which is a melanin-concentrating hormone (MCH) receptor 1 (MCHR1) antagonist that targets MCH neurons in the brain. It also develops ZYN002, a pharmaceutically manufactured synthetic cannabidiol.