Danavorexton: Treating Excessive Daytime Sleepiness in OSA

By Patrick Daly - Last Updated: June 9, 2023

Sleep disruptions in patients with obstructive sleep apnea (OSA) can lead to excessive daytime sleepiness (EDS), which can persist despite adequate compliance with continuous positive airway pressure (CPAP) therapy. Researchers, led by Richard K. Bogan, MD, evaluated danavorexton, a small-molecule orexin-2 receptor (OX2R) agonist, for the adjunct treatment of EDS due to OSA.

In their study, which was published in Sleep Medicine, they reported danavorexton improved objective and subjective sleep measures compared with placebo among patients with OSA and residual daytime sleepiness despite CPAP use. They also noted danavorexton improved wakefulness in patients who did not have orexin deficiency.

Danavorexton for Sleepiness in Patients With OSA 

The phase 1b study enrolled 25 patients aged 18 to 67 years with adequate CPAP use to receive 1 of 6 treatment schedules of single intravenous infusions of danavorexton 44 mg, danavorexton 112 mg, and placebo.

A total of 23 patients completed all treatment periods. The primary end points were adverse events and maintenance of wakefulness test (MWT), Karolinska Sleepiness Scale (KSS), and the psychomotor vigilance test (PVT) scores.

According to the authors, both the danavorexton 44 mg and 112 mg groups showed improvements in mean MWT, KSS, and PVT scores compared with the placebo group.

Among the 25 patients, 16 (64.0%) experienced treatment-emergent adverse events (TEAEs), and 12 (48%) had TEAEs judged to be related to danavorexton treatment. Additionally, urinary TEAEs were reported in 3 patients in the danavorexton 44 mg group, 7 in the 112 mg group, and no patients in the placebo group. No TEAEs leading to discontinuation of treatment or death occurred.

Overall, Dr. Bogan and colleagues supported that OX2R agonists can improve sleep-wake regulation and suggested “danavorexton may be a useful adjunct therapy for patients experiencing daytime sleepiness as a result of OSA.”

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