The Food and Drug Administration (FDA) has granted Fast Track designation to AD109 for the treatment of obstructive sleep apnea (OSA).
AD109 is an investigational, first-in-class, oral medication that contains atomoxetine, a selective norepinephrine reuptake inhibitor, and aroxybutynin, a selective antimuscarinic. AD109 works by activating the upper airway dilator muscles and maintaining an open airway during sleep.
The designation is supported by data from the phase 2 MARIPOSA study (ClinicalTrials.gov Identifier: NCT05071612), which included adults with mild to moderate OSA. Findings showed that patients treated with AD109 experienced a statistically significant and clinically meaningful difference from placebo in Hypoxic Burden, a measure of the total amount of respiratory event-related hypoxemia during sleep. The combination therapy was also found to be safe and well tolerated.
“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,” said Larry Miller, MD, CEO of Apnimed. “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.”
- Apnimed granted FDA Fast Track designation for AD109, a novel first-in-class oral pharmacologic combination for the treatment of obstructive sleep apnea (OSA). News release. Apnimed. Accessed June 28, 2022. https://www.businesswire.com/news/home/20220628005075/en/Apnimed-Granted-FDA-Fast-Track-Designation-for-AD109-a-Novel-First-in-Class-Oral-Pharmacologic-Combination-for-the-Treatment-of-Obstructive-Sleep-Apnea-OSA
- Apnimed announces positive phase 2 data (Study APC-004) demonstrating improvement in measures of obstructive sleep apnea and a dose-response with AD109, an oral pharmacologic treatment for the disease. News release. Apnimed. October 13, 2021. Accessed June 28, 2022. https://apnimed.com/apnimed-announces-positive-phase-2-data-study-apc-004-demonstrating-improvement-in-measures-of-obstructive-sleep-apnea-and-a-dose-response-with-ad109-an-oral-pharmacologic-treatment-for-the-disease/