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AD109 shows the potential to address an unmet need in obstructive sleep apnea treatment.
Positive results from the MARIPOSA phase 2b trial were revealed during the "Breaking News in OSA Mini Symposium" held at the American Thoracic Society (ATS) 2023 International Conference in Washington, DC. The study assessed the efficacy, safety, and dosage requirements of AD109 (aroxybutynin + atomoxetine), an oral therapy for patients with obstructive sleep apnea.1
Paula Schweitzer, PhD, study investigator and director of research at St. Luke’s Sleep Medicine and Research Center, presented the data at ATS and described details of the findings in an interview with HCPLive.
"This was a one-month duration study that demonstrated that AD109 showed clinically meaningful improvement in obstructive sleep apnea (OSA)," she said. "And that was in the form of decreasing the Apnea Hypopnea Index (AHI), and also exhibited improvement in daytime symptoms."
According to a statement from Apnimed, the development company, AD109 demonstrated a statistically significant reduction of AHI4 (P < 0.001) at both doses tested when compared with placebo.
The oral therapy has the potential to address an unmet need in obstructive sleep apnea treatment.
"Sleep apnea is a very common disorder with a lot of morbidity, and CPAP, the primary treatment for sleep apnea is incredibly effective, but it's not well tolerated," Schweitzer explained. "A lot of people won't use it, or can't use it, and even those that do, many of them are only using it for parts of the night."
The results displayed the drug's effectiveness in reducing AHI and suggested mitigation of daytime fatigue. Apnimed is aiming to initiate 2 phase 3 registration trials in the second half of 2023.
"There's been a long-term need for development of a pharmaceutical (for obstructive sleep apnea) and up until now, we have not had much success," Schwetizer said.