Potential solution for obstructive sleep apnea might be just steps away
In a significant breakthrough for those suffering from obstructive sleep apnea (OSA), pharmaceutical company Apnimed Inc. has reported positive results from its stage III clinical trial for the first oral pill for OSA. The lead candidate, AD109, showed clinically meaningful and statistically significant reductions in airway obstruction after 26 weeks.
The latest update on AD109 comes from the company's second Phase III trial, named LunAIRo, completed in July 2025. This trial demonstrated a significant reduction in the Apnea-Hypopnea Index (AHI)—a key measure of OSA severity—by 46.8% at 26 weeks compared to a 6.8% reduction with placebo.
These results confirm and reinforce the findings from an earlier Phase III trial, SynAIRgy, which showed a 55.6% average reduction in AHI. Together, these two pivotal trials provide strong evidence for AD109’s efficacy and safety as the first oral medication targeting OSA by increasing upper airway muscle tone during sleep.
Apnimed plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) by early 2026, aiming to secure approval. The FDA had previously granted AD109 Fast Track Designation, potentially expediting the review process. If approved, AD109 would be the first oral medication for OSA that addresses the root cause of the disease, offering a simpler alternative to current treatments like continuous positive airway pressure (CPAP) therapy.
OSA is a sleep disorder characterized by narrowed or blocked airways during sleep, causing pauses in breathing. People with OSA may experience loud snoring, followed by a long silent period, a loud snort, and gasp as they attempt to breathe. Excessive daytime sleepiness, poor quality of life, mental well-being, and cardiovascular health can be affected by OSA.
At the end of the trial, nearly 23% of participants saw "complete disease control." AD109 was well-tolerated in the trial with only mild or moderate adverse events and no serious adverse events reported. Lifestyle changes such as avoiding alcohol, medications that cause drowsiness, and losing excess weight can help manage OSA.
Meanwhile, the U.S. Food and Drug Administration (FDA) has expanded the approval of Eli Lilly's obesity medication Zepbound to include treating moderate to severe OSA for people with obesity. However, it's important to note that this medication is not a cure for OSA and should be used in conjunction with lifestyle changes and other treatments as recommended by a healthcare provider.
As the fight against OSA continues, the development of AD109 brings hope for a simpler and more effective treatment option for those affected by this sleep disorder.
- The clinical trial results for AD109, an oral pill for obstructive sleep apnea (OSA), show a substantial decrease in airway obstruction, which could significantly contribute to an individual's health-and-wellness.
- The positive outcomes from Apnimed Inc.'s Phase III trials demonstrate a reduction in the Apnea-Hypopnea Index (AHI), a key measure of OSA severity, by a considerable margin, suggesting that AD109 could potentially improve the climate of sleep for many who suffer from this sleep disorder.
- Science has taken a substantial step forward with the development of AD109, as it represents the first oral medication targeting OSA, offering a potential simpler alternative to existing treatments like continuous positive airway pressure (CPAP) therapy, and addressing the root cause of the disease.
- Good sleep quality is vital for overall health and wellness, and the development of AD109, if approved, may provide a new avenue for managing OSA, ultimately improving the lifestyle and health of those affected by the sleep disorder. Additionally, maintaining a healthy lifestyle through avoiding alcohol, certain medications, and losing excess weight can further help those with OSA.
