On June 28, 2022, Apnimed announced that the FDA has granted Fast Track designation to AD109, its novel oral pharmalogic for the treatment of obstructive sleep apnea (OSA).
About AD109
AD109 is a novel investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity. The drug has the potential to be the first oral pharmacologic that treats OSA airway obstruction at night.
According to the company, AD109 combines the norepinephrine reuptake inhibitor atomoxetine and the novel antimuscarinic agent aroxybutynin. It targets key neurological pathways in OSA that cause upper airway obstruction during sleep by activating the upper airway dilator muscles and maintaining an open airway during sleep.
The FDA’s Fast Track designation is “a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.”
Currently, AD109 is completing Phase 2 clinical trials, after which Apnimed plans to meet with the FDA to discuss the Phase 3 development program.
About obstructive sleep apnea
OSA is a serious sleep disorder where the airway becomes repeatedly blocked during sleep, causing pauses in breathing. This condition, often marked by loud snoring and choking noises, can lead to oxygen deprivation, disrupting sleep and contributing to various health issues such as high blood pressure, heart disease, stroke and diabetes.
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