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Harmony Biosciences to Present New Data Analyses for Wakix (Pitolisant) At the Sleep 2021 Annual Meeting

  • Two Poster Presentations Will Include New Post-Hoc Analyses That Highlight the Clinical Effectiveness of Wakix

Harmony Biosciences Holdings, Inc., a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, announced that results from two post-hoc analyses from the clinical development program for WAKIX will be presented at the 35th Annual Meeting of the Associated Professional Sleep Societies (APSS), known as “SLEEP 2021.” The meeting will be held virtually June 10-13.

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One of the poster presentations is a new analysis that calculated the number needed to treat (NNT) and effect size of WAKIX to demonstrate the magnitude of its clinical effectiveness. The second poster is based on an analysis of the cataplexy data from the clinical development program for WAKIX.

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“The analyses that we are presenting at the SLEEP conference this year highlight the strength of the efficacy data for WAKIX,” said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. “The analyses include both a traditional approach to presenting efficacy data, as well as one that underscores the clinical relevance of the findings, using NNT and effect sizes to capture overall clinical benefit.”

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The data being presented by Harmony will be available in the meeting’s ePoster gallery beginning June 9 through November 30, and includes:

  • Assessment of the Clinical Benefits of Pitolisant on Excessive Daytime Sleepiness and Cataplexy in Adults With Narcolepsy (Poster 504). Meskill, G, Davis, C, Zarycranski, D, Doliba, M, Schwartz JC, Dayno, J.
    • Analysis evaluating number needed to treat and effect sizes for treatment with pitolisant for excessive daytime sleepiness and cataplexy from the HARMONY-1 and HARMONY-CTP randomized, controlled, 7- or 8-week trials in adults with narcolepsy.
  • Efficacy of Pitolisant in the Treatment of Cataplexy in Adults With Narcolepsy (Poster 505). Davis, C, Zarycranski, D, Doliba, M, Dayno, J, Schwartz, JC.
    • Analysis evaluating the frequency of cataplexy attacks during treatment with pitolisant from the HARMONY-1 and HARMONY-CTP randomized, controlled, 7- or 8-week trials in adults with narcolepsy.

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