FDA Approves Amzeeq Minocycline Foam from Foamix

The FDA has approved Amzeeq (minocycline) topical foam, 4%, from Foamix Pharmaceuticals for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older. Amzeeq, formerly known as FMX101, is the first topical minocycline to be approved by the FDA for any condition. It is expected to be available January 2020.

The approval is supported by data from three Phase 3 clinical trials in 2,418 patients nine years of age or older. In each 12-week, multicenter, randomized, double-blind, vehicle-controlled study, subjects with moderate to severe acne vulgaris were treated once-daily with Amzeeq or vehicle. No other topical or systemic acne medication was permitted to be used by subjects during the study period. The studies each found statistically significant disease improvement with Amzeeq versus vehicle for the co-primary endpoint of absolute reduction of inflammatory lesions, while studies 2 and 3 demonstrated a statistically significant improvement in IGA treatment success. IGA treatment success was defined as a score of 0 (“clear”) or 1 (“almost clear”) and at least a two-point decrease from baseline. Amzeeq was well-tolerated and no treatment-related serious adverse events were reported. The most common adverse reaction was headache, which was reported in 3% of subjects treated with Amzeeq versus 2% of subjects treated with vehicle.

Amzeeq utilizes the proprietary Molecule Stabilizing Technology (MST™) platform from Foamix to effectively deliver minocycline in a foam-based vehicle. 

“The FDA approval of Amzeeq is a milestone moment in dermatology and the most significant advancement with minocycline in almost 50 years,” saysDavid Domzalski, Chief Executive Officer of Foamix. “We are proud that our proprietary technology platform has led to this new treatment option, which we believe can help address unmet treatment needs for moderate to severe acne patients. We are looking forward to bringing Amzeeq to market in January 2020, and to our Company’s first commercial launch.”