A novel breakthrough oral pharmacologic drug, AD109, has been discovered by Apinmed for the treatment of patients with OSA.
The US Food and Drug Administration (FDA) has given its fast track designation for the drug.
AD109 is an investigational, first-in-class, oral medication that contains atomoxetine, a selective norepinephrine reuptake inhibitor, and aroxybutynin, a selective antimuscarinic.
The oral drug works by activating the upper airway dilator muscles and maintaining an open airway during sleep.
Currently, AD109 is completing Phase 2 clinical trials, after which Apnimed will begin with the trial design for its Phase 3 program, which is expected to be initiated in late 2022.
Obstructive Sleep Apnea (OSA) is one of the most common and serious sleep disorders and is characterized by partial or complete upper airway obstruction that occurs during sleep, which often leads to poor sleep and, in the long term, has been shown to exacerbate hypertension, diabetes, cardiovascular disease, and stroke.
Additionally, OSA can impair work productivity, reduce functional ability, and lower quality of life.
Sleep-related muscular relaxation driven by the central nervous system is the key neurologic mechanism that causes OSA.
In patients with OSA, a reduction in neuromuscular control of the upper airway during sleep leads to a corresponding relaxation of the upper airway dilator muscles.
The vast majority of diagnosed patients are prescribed positive air pressure therapy devices such as continuous positive airway pressure, or CPAP, but many patients are dissatisfied with these mechanical nighttime devices, and fewer than half are compliant long-term, leaving a significant population untreated, undertreated, and at risk.
