Harmony Biosciences Holdings Inc will present new data on the safety and efficacy of WAKIX (pitolisant), including four poster presentations at Virtual SLEEP 2020. Abstracts of the WAKIX data will also be published in the journal Sleep as an online supplement.
The data include a final analysis of the Pitolisant Expanded Access Clinical Evaluation Program (PEACE), two post-hoc analyses on clinically relevant outcomes from the Phase 3 clinical trials, and analyses that further characterize the cardiac safety profile of WAKIX from the clinical development program.
“We continue to analyze the extensive database from the clinical development program for WAKIX and are pleased to have the opportunity to highlight new analyses that demonstrate clinically relevant outcomes for WAKIX in the treatment of adult patients with narcolepsy,” says Harmony’s chief medical officer, Jeffrey Dayno, MD, in a release. “These analyses add to the growing body of scientific evidence supporting WAKIX and validate our commitment to continuing to provide patients and their healthcare providers with important information about this treatment option.”
The data being presented by Harmony include:
- Safety and Tolerability of Pitolisant in the Treatment of Adult Patients With Narcolepsy: Final Analysis of An Open-Label, Expanded Access Program in the United States (Poster 0766) E Bauer, C Davis, A Patroneva, J Dayno, M Thorpy. Results from a final analysis of the Pitolisant Expanded Access Clinical Evaluation (PEACE) Program, which provided adult patients in the U.S. living with narcolepsy access to treatment with pitolisant before its approval by the U.S. Food and Drug Administration (FDA).
- Time Course of Improvement in Excessive Daytime Sleepiness and Cataplexy During Treatment with Pitolisant in Patients with Narcolepsy (Poster 0768) A Roy, C Davis, B Vaughn, J Dayno, Y Dauvilliers, J-C Schwartz. Analysis evaluating the time-to-response of pitolisant for both excessive daytime sleepiness and cataplexy from three randomized, placebo-controlled studies in adult patients with narcolepsy.
- Efficacy of Pitolisant in Patients with High Burden of Narcolepsy Symptoms (Poster 0762) C Davis, U Kallweit, L Krahn, B Vaughn, M Thorpy. Results from a post-hoc analysis evaluating the efficacy of pitolisant in patients who had a high burden of the main narcolepsy symptoms of excessive daytime sleepiness and cataplexy at baseline. Data were pooled from two randomized, placebo-controlled studies of pitolisant in adult patients with narcolepsy.
- Cardiac Safety Profile of Pitolisant in Patients with Narcolepsy (Poster 0744) W Winter, S Wanaski, A Patroneva, J Dayno. Analysis of the cardiac safety profile of pitolisant in adults with narcolepsy from the clinical development program.