Promising Developments in Pharmaceutical Treatments for Sleep Apnea: Sanjay R. Patel, MD, MS

WATCH TIME: 5 minutes

"There's a huge unmet need for all of these patients with sleep apnea, and there's a range of different treatment options being developed."

Currently, there are no approved pharmacologic therapies available for the treatment of patients with obstructive sleep apnea (OSA). AD109 (Apnimed), a first-in-class once-daily medication combining antimuscarinic aroxybutynin and atomoxetine, aims to be the first oral pharmacologic therapy for OSA by targeting key neurological pathways that activate upper airway dilator muscles to maintain an open airway during sleep. At the 2024 SLEEP Annual Meeting, held June 1-5, in Houston, Texas, investigators presented an outline of the phase 3 SynAIRgy trial (NCT05813275), a randomized, controlled study evaluating the efficacy and safety of AD109 as a potential treatment for OSA.¹

The study, which is currently ongoing, includes approximately 640 participants with OSA who are randomly assigned 1:1 to either AD109 or placebo for a 26-week treatment period. Those in the trial are adults who either decline or unable to tolerate continuous positive airway pressure treatment, otherwise considered the gold standard for OSA. In addition, eligible patients have an apnea-hypopnea index (AHI)-4 (4%)(desaturation definition for hypopneas) greater than 5 and a body mass index less than 42 kg/m2 for women and less than 40 kg/m2 for men. The primary end point is response rate of AD109 vs placebo, defined as at least a 50% reduction in AHI4 over the 26-week period using a polysomnogram.

More recently, Apnimed announced early completion of enrollment for their LunAIRo phase 3 study (NCT05811247), an additional trial assessing AD109 in patients with OSA, comparing the treatment to placebo at 6 months and 1 year.2 Primary investigator and attendee of SLEEP 2024 Sanjay R. Patel, MD, MS, professor of medicine, epidemiology, & clinical and translational science at University of Pittsburgh, recently had an interview with NeurologyLive^® to further discuss the methodology of LunAIRo. Patel, who also serves as the director of the Center for Sleep and Cardiovascular Outcomes Research and medical director of the UPMC Comprehensive Sleep Disorders Program, talked about the need to address neuromuscular dysfunction that causes OSA, and the implications of an oral medication for patients with OSA.

Click here for more coverage of SLEEP 2024.

REFERENCES
1. Strollo P, Taranto-Montemurro L. Aroxybutynin and Atomoxetine for the Treatment of OSA: Rationale and Design of the SYNAIRGY Phase 3 RCT. Presented at: 2024 SLEEP Annual Meeting; June 1-5; Houston, TX. ABSTRACT 0546.
2. Apnimed Announces Completion of Enrollment in Phase 3 LunAIRo Study of AD109, the Potential First Nighttime Oral Treatment for Obstructive Sleep Apnea. News Release. Published May 9, 2024. Accessed June 12, 2024. https://apnimed.com/completion-of-phase-3-enrollment-lunairo-study-ad109-osa/