The FDA has approved minocycline topical foam 4% (Amzeeq, Foamix) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years and older.
Minocyclin is a tetracycline-class drug that was originally approved as an oral formulation in 1971.
“The approval of AMZEEQ is exciting news that provides a much-needed option in the treatment of moderate to severe acne,” said Linda Stein Gold, MD, director of Dermatology Clinical Research and Division Head of Dermatology at Henry Ford Health System in Detroit, MI in a statement. “Minocycline has been a trusted staple in acne treatment for decades, but has only been available in oral or systemic formulations. With the approval of AMZEEQ, I can now offer my patients a new, effective topical treatment option with a favorable tolerability profile.”
The recent approval was based upon the results of three phase 3 clinical trials that included 2,418 patients. In each 12-week, multi-center, randomized, double-blind, vehicle-controlled study, patients with moderate to severe acne vulgaris were treated with either minocycline topical foam 4% or vehicle foam.
According to Foamix, the studies found a statistically significant disease improvement with the minocycline topical foam versus vehicle for co-primary endpoint of absolute reduction of inflammatory lesions. Specifically, studies 2 and 3 demonstrated statistically significant improvement in IGA—measured as a score of 0 (clear) or 1 (almost clear) and at least a two-point decrease from baseline. Minocycline foam was also reportedly well-tolerated with no treatment-related serious adverse events reported throughout the trials.
Minocylcine topical foam 4% is contraindicated in patients with a hypersensitivity to any of the tetracycline or other ingredients within Amzeeq.
The topical foam will be available for prescribing in January 2020.