Minocycline Approved by FDA for Treatment of Moderate to Severe Acne Vulgaris

Published Online: Monday, October 21st, 2019
Officials from the FDA have approved Foamix Pharmaceuticals’ minocycline (AMZEEQ) topical foam, 4%, for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris. This is the first topical minocycline to be approved by the FDA for any condition, according to the company.
The approval is supported by results from three Phase 3 clinical trials, which evaluated 2,418 patients in 12 weeks. Patients of 9 years and older were treated with minocycline or vehicle once a day.
Results showed that minocycline was statistically significant in disease improvement versus the vehicle in the studies. Meanwhile, studies 2 and 3 demonstrated statistically significant improvement in IGA treatment success.
The most common adverse reactions from minocycline was headache, which was reported in 3% of subjects.
Foamix receives FDA approval of AMZEEQ topical minocycline treatment for millions of moderate to severe acne sufferers [news release]. Rehovot, Israel and Bridgewater, NJ; Foamix Press Releases: October 18, 2019. https://www.foamix.com/news-releases/news-release-details/update-foamix-receives-fda-approval-amzeeqtm-topical-minocycline. Accessed October 21, 2019.

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