Foamix Pharmaceuticals Ltd. said the U.S. Food and Drug Administration approved Amzeeq to treat moderate to severe acne in patients aged nine years and older.
The U.S. regulator authorized the use of Amzeeq, or minocycline, to treat inflammatory lesions due to acne. Minocycline is an antibiotic used for treating acne but had limited oral use due to side effects in certain patients.
Amzeeq, formerly known as FMX101, uses Foamix's proprietary technology to deliver the drug in a topical foam. This is the first topical minocycline to be approved by the FDA for any condition, according to an Oct. 18 news release.
The approval is based on results from three late-stage clinical trials of Amzeeq in acne patients aged nine years and older which showed that the drug significantly improved symptoms of the disease. The drug also showed significant improvement in clearing the skin of the patients.
The Israel-based company, which develops and commercializes treatments for skin conditions in the U.S. and Germany, expects to make the drug available in January 2020.