Researchers will present clinical data on the efficacy and safety of the medication pitolisant (WAKIX) for the treatment of excessive daytime sleepiness in adult patients with narcolepsy during the World Sleep 2019 meeting in Vancouver, Canada from Sept. 20-25, according to a press release from the biopharmaceutical company Harmony Biosciences.
In a presentation, results will be presented from a randomized, double-blind study that evaluated the abuse potential of pitolisant compared with the stimulant phentermine HCl (C-IV) and placebo in nondependent recreational stimulant users. In addition, seven scientific posters will be presented, including a new post hoc analysis of pooled data from two randomized, placebo-controlled studies of pitolisant in adults with narcolepsy that evaluated the efficacy of the treatment in patients with a high burden of narcolepsy symptoms.
Pitolisant was recently approved by the US Food and Drug Administration (FDA) for the treatment of excessive daytime sleepiness in adult patients with narcolepsy.
“Harmony looks forward to sharing clinical data for WAKIX at the World Sleep 2019 meeting, which will shed light on its product profile as the first and only approved treatment for patients with narcolepsy that is not scheduled as a controlled substance,” Harmony’s chief medical officer, Jeffrey Dayno, MD, says in a statement.
“These data reflect the breadth of scientific evidence in support of WAKIX, and further demonstrate its uniqueness as a first-in-class molecule with a novel mechanism of action. We look forward to presenting these data to a global audience,” says Dayno.
The abstracts being presented include:
- Oral Presentation: Evaluation of Abuse Potential of the Narcolepsy Medication Pitolisant (September 25, 4:30-6 pm) J Dayno, C Scart-Grès, P Robert, J-C Schwartz, B Setnik.
- Poster Presentation: Efficacy of Pitolisant in Patients with High Burden of Narcolepsy Symptoms (September 24, 5:30-7 pm) C Davis, L Krahn, B Vaughn, M Thorpy.
- Poster Presentation: The Safety and Tolerability of Pitolisant in the Treatment of Excessive Daytime Sleepiness and Cataplexy in Adult Patients with Narcolepsy: An Open-Label, Expanded Access Program in the United States (September 24, 5:30-7 pm) E Bauer, C Davis, A Patroneva, J Dayno, M Thorpy.
- Poster Presentation: Long-Term Evaluation of Safety and Efficacy of Pitolisant in Narcolepsy: HARMONY 3 Study (September 23, 5:30-7 pm) Y Dauvilliers, I Arnulf, C Scart-Grès, I Lecomte, C Caussé, J Dayno, J-C Schwartz.
- Poster Presentation: Safety and Tolerability of Pitolisant in the Treatment of Adults with Narcolepsy: Integrated Data from Clinical Studies (September 23, 5:30-7 pm) C Scart-Grès, C Momah, M Roy, K Maski, S Piris, R Bogan.
- Poster Presentation: Efficacy and Safety of Pitolisant in Patients With Narcolepsy: A Review of Clinical Trials (September 24, 5:30-7 pm) Y Dauvilliers, J-C Schwartz, C Davis, J Dayno.
- Poster Presentation: Pitolisant in Combination With Other Medications for the Management of Narcolepsy (September 23, 5:30-7 pm) K Doghramji, C Davis, A Patroneva, J-C Schwartz, C Scart-Grès, P Robert, T Duvauchelle, S Wanaski, A Krystal.
- Poster Presentation: Burden of Narcolepsy: A Survey of Patients and Physicians (September 23, 5:30-7 pm) M Thorpy, J Hopper, A Patroneva.