Foamix Pharmaceuticals (FOMX) on Monday reported safety data from the study of its FDA-approved Amzeeq for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients nine years of age and older.
The company conducted safety studies to support the new drug application submission of Amzeeq. The studies enrolled 657 patients who had completed 12 weeks of Amzeeq and among those patients, 291 completed 52 weeks of therapy and the treatment was consistent with scores obtained at week 12.
Adverse events at the application site were seen in less than 2% of patients. No severe local tolerability scores and no serious drug-related adverse events were reported.