The Food and Drug Administration (FDA) has approved Amzeeq (minocycline; Foamix) topical foam 4% for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged 9 years and older.

Amzeeq, previously known as FMX101, uses Foamix’s proprietary Molecule Stabilizing Technology (MST) platform to deliver minocycline, a tetracycline-class drug, in a foam formulation; it is the first FDA-approved topical minocycline treatment for moderate to severe acne vulgaris. 

The approval is supported by data from three 12-week, multicenter, double-blind, phase 3 trials (Study 1 [NCT02815267], Study 2 [NCT02815280], and Study 3 [NCT03271021]) in patients aged 9 years and older with moderate to severe acne vulgaris (N=2418). Patients were randomized to receive either Amzeeq once daily or vehicle and were not permitted to use any other topical or systemic acne medication during treatment. 

Results demonstrated that at Week 12, the Amzeeq treatment arm achieved both co-primary efficacy end points with a statistically significant improvement in absolute reduction of inflammatory lesions in each study, and in Investigator’s Global Assessment (IGA) treatment success in studies 2 and 3 (defined as a score of 0 [“clear] or 1 [“almost clear”] and a ≥2-point decrease from baseline).  

Regarding safety, the most common adverse reaction in clinical trials was headache. Amzeeq was well-tolerated with no reported treatment-related serious adverse events. 

“Minocycline has been a trusted staple in acne treatment for decades, but has only been available in oral or systemic formulations,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research and Division Head of Dermatology at Henry Ford Health System in Detroit, Michigan. “With the approval of Amzeeq, I can now offer my patients a new, effective topical treatment option with a favorable tolerability profile.”

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The Company expects Amzeeq to be available in January 2020. The product will be supplied in a 30-gram aerosol container.

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