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Harmony Biosciences Presents Efficacy And Safety Analyses For WAKIX® (pitolisant) At Virtual SLEEP 2020
Post-hoc analyses evaluate time-to-response, efficacy in high burden of narcolepsy symptoms, and overall cardiovascular safety profile in patients with
About this update from Harmony Biosciences Holdings, Inc.
[{"type":"text","content":"Post-hoc analyses evaluate time-to-response, efficacy in high burden of narcolepsy symptoms, and overall cardiovascular safety profile in patients with narcolepsy\n\n\nPLYMOUTH MEETING, Pa. and CHICAGO, Aug. 28, 2020 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (\"Harmony\") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, announced today results from post-hoc analyses of the efficacy and safety data for WAKIX® (pitolisant) presented at the 34th Annual Meeting of the Associated Professional Sleep Societies (APSS), known as \"SLEEP 2020.\" The meeting is being held virtually from August 27—30. Harmony is presenting a total of four posters in the Virtual SLEEP 2020 Exhibit Hall, three of which are post-hoc analyses of the efficacy and safety data from the clinical development program for WAKIX.\n\n \n \n \n \n \n \n\n \n\"We are pleased to participate in this year's SLEEP 2020 virtual meeting and share clinically relevant data supporting WAKIX with healthcare professionals and the sleep medicine community,\" said Harmony's Chief Medical Officer, Jeffrey Dayno, M.D. \"The results presented from post-hoc analyses of the clinical data help further characterize the efficacy and safety profile of WAKIX to assist healthcare professionals in making treatment decisions for their patients living with narcolepsy.\"\nTime-to-Response in Excessive Daytime Sleepiness and Cataplexy During Treatment with Pitolisant in Patients with Narcolepsy \nThis poster presents results from a post-hoc analysis that examined the time-to-response to pitolisant on improvement in both excessive daytime sleepiness (EDS) and reduction in cataplexy based on pooled data from the HARMONY 1 and HARMONY CTP randomized, controlled clinical trials. Pitolisant was titrated to a maximum dose of 35.6 mg/day and the change from baseline in mean Epworth Sleepiness Scale (ESS) scores (in both studies) and mean weekly rate of cataplexy (WRC; in HARMONY CTP) was compared for pitolisant versus placebo. \nIn the HARMONY 1 (pitolisant, n=31; placebo, n=30) and HARMONY CTP (pitolisant, n=54; placebo, n=51) trials, the ESS score improvement was significantly greater with pitolisant versus placebo beginning at Week 2 (LS mean difference, -2....