Biopharmaceutical company Aculys Pharma Inc has initiated a phase 3 clinical study in Japan of pitolisant, a histamine H3 receptor antagonist/inverse agonist, in patients with obstructive sleep apnea (OSA) who have excessive daytime sleepiness despite receiving continuous positive airway pressure (CPAP) therapy.
The trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study (part 1) and a subsequent multi-center, open-label, long-term extension study (part 2) to assess the safety and efficacy of the drug in the Japanese patient population.
Some sleep apnea patients experience persistent excessive daytime sleepiness despite CPAP. Excessive daytime sleepiness is considered a risk factor for impact on labor productivity, reduced quality of life, and accidents, so new treatment options are needed, says a press release by Aculys Pharma, which has an exclusive license to develop and commercialize pitolisant in Japan.
Pitolisant, developed by Paris-based Bioprojet, was approved by the European Medicines Agency for the treatment of excessive daytime sleepiness associated with OSA in 2021 and has since been available as brand name OZAWADE in the clinical setting in Europe.
In the United States, pitolisant was approved by the Food and Drug Administration for the treatment of excessive daytime sleepiness associated with narcolepsy in 2019 and cataplexy associated with narcolepsy in 2020.