The US Food and Drug Administration has approved minocycline topical foam, 4% for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgarism in adults and pediatrics patients 9 years of age or older.
The United States Food and Drug Administration has approved a novel minocycline topical foam, 4% (AMZEEQ) for treatment of inflammatory lesion of non-nodular moderate to severe acne vulgarism in adults and pediatrics patients 9 years of age or older.
The approval of minocycline topical foam, which was awarded to Foamix Pharmaceuticals, marks the first time a topical minocycline has been approved by the FDA for any condition.
"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, Michigan. "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."
Minocycline topical foam, 4% was supported by data from 3 phase 3 clinical trials that examined its use in 2418 patients 9 years of age and older. Each trial used in the application to the FDA was 12 weeks in length and designed as multicenter, randomized, double-blind, vehicle-controlled studies.
Individuals included in the clinical program had moderate to severe acne vulgaris and were treated once-daily with minocycline topical foam or vehicle. Results of the studies revealed patients achieved statistically significant disease improvement with the therapy compared with vehicle for the primary endpoint of reduction of inflammatory lesions.
Additionally, in studies 2 and 3, a statistically significant improvement in IGA treatment success was noted by investigators. In regard to safety, minocycline topical foam was well-tolerated and no treatment-related serious adverse events were reported.
Foamix Pharmaceuticals noted in a press release they expected minocycline topical foam, 4% to be available for prescribing in January 2020.
"The approval of AMZEEQ represents a significant step toward our goal of enhancing the standard of care for the millions of acne sufferers in the U.S. who deserve alternatives in treatment," said Iain Stuart, PhD, chief scientific officer of Foamix.