Aculys Pharma initiates phase 3 trial for excessive daytime sleepiness treatment

Aculys Pharma, Inc. announced the initiation of a phase 3 trial of pitolisant, a histamine H3 receptor antagonist/inverse agonist in those with excessive daytime sleepiness that is associated with obstructive sleep apnea syndrome.

According to a release from the company, the trial will be broken up into two parts — the first is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study; while the second part will be a subsequent multi-center, open-label, long-term extension study that will assess the safety and efficacy of the treatment.

Developed by French company Bioprojet, pitolisant was approved by the European Medicines Agency in 2021, and has been available for clinical use since then, the release stated.

The release stated that obstructive sleep apnea syndrome is characterized by an interruption of proper breathing due to the narrowing or obstruction of the upper airway during sleep. Symptoms include snoring, daytime sleepiness, insomnia, fatigue, and the sense of insufficient sleep.

According to the release, continuous positive airway pressure, or CPAP, is considered the standard treatment for obstructive sleep apnea syndrome. However, some patients experience excessive daytime sleepiness despite basic treatment.