Two analyses from the clinical development program for Harmony Biosciences Holdings Inc’s WAKIX (pitolisant) are showcased at the 2021 American Academy of Neurology (AAN) Annual Meeting, held virtually April 17-22.
One of the poster presentations is based on a post-hoc analysis that evaluated the time-to-onset of clinical response for WAKIX and the second poster is based on a pooled analysis of the cardiovascular safety data from the clinical development program for WAKIX in adult patients with narcolepsy.
“These analyses further characterize the efficacy and safety profile of WAKIX and its broad clinical utility for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy,” says Harmony’s chief medical officer, Jeffrey Dayno, MD, in a release. “We look forward to sharing these data and the results of these analyses with both the neurology and narcolepsy communities.”
The abstracts are:
Time to Onset of Clinical Response During Treatment with Pitolisant (P26.015). C Davis, J Dayno, B Vaughn, Y Dauvilliers.
Analysis evaluating the time-to-onset of clinical response during treatment with pitolisant for excessive daytime sleepiness and cataplexy from the HARMONY-1 and HARMONY-CTP randomized, controlled trials in adults with narcolepsy.
Cardiac Safety Profile of Pitolisant in Patients with Narcolepsy (P26.016). W Winter, S Wanaski, A Patroneva, J Dayno.
Results from pooled analysis of two randomized, placebo-controlled seven-or eight-week studies and from a 12-month, open-label study evaluating the cardiac safety profile of pitolisant in adults with narcolepsy from the clinical development program.