New Drug Readies for Phase 3 Trials
Currently known only as “AD109,” the sleep apnea drug showed promise in its Phase 2 clinical trial. Now the drugmaker, Apnimed, is preparing to move into Phase 3 development after one more Phase 2 trial.
We’ll provide a basic rundown of the normal clinical phases of drug development to help you understand how important this is.
In Phase 1, researchers look mostly at the safety of the drug. Typically involving a few dozen volunteers (which might include both healthy individuals and those with the targeted condition), researchers make sure the drug doesn’t have any deadly effects and try to hone in on a potential dosage. Approximately 70% of drugs move past Phase 1.
In Phase 2, researchers want to see if the drug really works. Using from one to a few potential dosages determined in Phase 1, up to several hundred participants take the drug between months and years. In addition to checking efficacy, researchers look for any concerning side effects triggered by the potential doses. Approximately 33% of drugs pass Phase 2.
In Phase 3, there may be thousands of people taking the developmental drug. Studies take from 1 to 4 years to look at long-term efficacy and safety. About 25% of drugs make it past Phase 3.
After Phase 3, a manufacturer can request marketing approval from the FDA. The FDA evaluates all the clinical trials as well as the need for the drug before approving it.
Once approved, a drug moves on to Phase 4, also known as Postmarket Monitoring. Large studies and reports to the FDA look for adverse effects. If sufficient safety concerns arise, the FDA might decide to pull the drug from the market.
Based on this timetable, AD109 might be as little as 2-5 years away from pharmacy shelves in Omaha.