Apnimed believes there is a market for a new pharmaceutical therapeutic option for OSA, which affects 25 million Americans.
Muscles that normally maintain the upper airway open collapse periodically during sleep in these people, resulting in occasional low oxygen levels and long-term morbidity.
Although continuous positive air pressure can be useful, many patients do not adhere to the treatment, which necessitates the use of a mask while sleeping.
Neurostimulation implants are also useful, although some individuals are disqualified for them and others are unwilling to go through the necessary surgical process.
Aptimed’s AD109 combines atomoxetine, a selective norepinephrine reuptake inhibitor, with aroxybutynin, an antimuscarinic, to activate upper airway dilator muscles and keep the airway open during sleep.
The medication is presently being evaluated in the Mariposa phase 2 trial, one of the largest clinical trials for a therapeutic candidate focused at treating the underlying etiology of OSA.
Apnimed plans to engage with the FDA regarding the phase 3 development program after the trial is completed.