Harmony Biosciences Holdings Inc presented data from three analyses of the clinical development program for WAKIX (pitolisant), a medication approved for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy, at the 2021 American Psychiatric Association (APA) Annual Meeting, held virtually May 1-3.
This is the first time Harmony has shared WAKIX data directly with the psychiatry and mental health professional communities. Sleep disorders are highly comorbid with a multitude of psychiatric disorders and narcolepsy can have a significant impact on a person’s daily functioning, which may greatly affect their social, emotional and psychological well-being, and quality of life.
Two of the three poster presentations feature analyses of efficacy and safety data from the clinical development program for WAKIX in adult patients with narcolepsy and the third is based on a post-hoc analysis that evaluated the time to onset of clinical response for WAKIX.
“Both excessive daytime sleepiness and cataplexy can have a significant impact on a person’s daily functioning, which may greatly affect their social, emotional, and psychological well-being,” says Harmony’s chief medical officer, Jeffrey Dayno, MD, in a release. “Given this, and the fact that sleep disorders are comorbid with several different psychiatric disorders, we are pleased to share these data for WAKIX with the psychiatry and mental health professional communities for the first time.”
[RELATED: WAKIX Time-to-Onset & Cardiovascular Safety Data Presented at AAN 2021]
The data presented by Harmony includes:
Efficacy and Safety of Pitolisant in the Treatment of Excessive Daytime Sleepiness in Adult Patients With Narcolepsy: A Review of Clinical Trials (Poster 4463). L Krahn, C Davis, J-C Schwartz, J Dayno.
Analysis of results from HARMONY 1 and HARMONY 1bis, two pivotal randomized, placebo-controlled, 8-week trials that assessed the efficacy and safety of pitolisant for the treatment of excessive daytime sleepiness in adults with narcolepsy.
Efficacy of Pitolisant, a Selective Histamine 3 (H3)-Receptor Antagonist/Inverse Agonist, in the Treatment of Cataplexy in Patients With Narcolepsy (Poster 4460). M Thorpy, J-C Schwartz, C Caussé, J Dayno.
A review of results from HARMONY 1, HARMONY 1bis, HARMONY CTP and HARMONY 3 Phase 3 clinical trials, which assessed safety and efficacy of pitolisant for the treatment of cataplexy in adults with narcolepsy.
Time Course of Improvement in Excessive Daytime Sleepiness and Cataplexy During Treatment with Pitolisant in Patients with Narcolepsy (Poster 4469). C Davis, J Dayno, B Vaughn, Y Dauvilliers, J-C Schwartz.
Analysis evaluating the time-to-response to treatment with pitolisant for excessive daytime sleepiness and cataplexy from the HARMONY-1 and HARMONY-CTP randomized, placebo-controlled trials in adults with narcolepsy.