The US Food and Drug Administration (FDA) has granted Fast Track designation for Apnimed’s oral pharmacologic AD109 for the treatment of obstructive sleep apnea (OSA).
“Fast Track designation is a significant milestone in the development of AD109 and provides an accelerated regulatory pathway that recognizes the urgent need for new pharmacologic treatments for OSA that are easier for people to tolerate,” says Larry Miller, MD, Apnimed CEO, in a release. “Currently the vast majority of more than 35 million Americans who have OSA remain untreated despite the potential for serious health risks associated with the condition, including cardiovascular disease and diabetes. We will continue to work closely with the FDA to support the development and review of AD109 beginning with the trial design for our Phase 3 program, which we anticipate initiating at the end of 2022.”
FDA’s Fast Track designation is intended to facilitate the development and expedite the review of new drugs to treat serious conditions and that fill an unmet medical need. The benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss development plans, trial design, and data needed to support drug approval, as well as the ability to submit a New Drug Application on a rolling basis, and eligibility for priority review, if relevant criteria are met.
Apnimed’s AD109 has the potential to be the first oral pharmacologic that treats OSA airway obstruction at night. It is a first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity. AD109 combines a selective norepinephrine reuptake inhibitor (atomoxetine) with Apnimed’s new chemical entity and selective antimuscarinic (aroxybutynin). AD109 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. AD109 is currently completing Phase 2 clinical trials, after which Apnimed plans to meet with FDA to discuss the Phase 3 development program.