Promising (If Limited) Results in Phase 2 Trial
The sleep apnea drug that is closest to development is currently called AD109. It reported its phase 2 trial results over the summer.
This drug attempts to stimulate the muscles of the airway to help them hold it open during sleep. This would reduce the likelihood of an obstructive sleep apnea attack. With fewer apneic attacks, a person would experience less time with damaging oxygen shortages that can trigger high blood pressure, nightly awakenings, and other consequences of sleep apnea.
Trial Phases for FDA Approval
To be approved for sale by the Food and Drug Administration (FDA), a drug must successfully complete three phases of trials.
In phase 1 trials, researchers give the drug in very small doses to make sure it’s not too dangerous and that it has at least a chance of success. In phase 2 trials, researchers give the drug to a larger population. Typically, they try more than one dosage of the drug at this phase in an attempt to determine the proper dosage for effective use. Researchers continue to monitor safety, but the goal here is to prove that the drug works.
In phase 3 trials, human testing is expanded to typically thousands of people at multiple trial centers, with the goal of gathering enough evidence to win approval by the FDA. The FDA considers approval after the successful completion of phase 3.
After phase 3, the FDA will monitor a drug as it gets widely released. Sometimes called a phase 4 trial, the FDA checks reports about the drug’s effectiveness and side effects.
In its phase 2 trial, AD109 helped people with sleep apnea drop their average apnea-hypopnea rate from nearly 14 to under 6 at the higher dose. This is still mild sleep apnea, but it’s not so severe that it necessarily requires treatment. These results are considered good enough that the drug can go on to phase 3.