FDA Approves Minocycline Topical Foam for Acne Vulgaris
Minocycline topical foam, 4% is indicated for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in adults and pediatric patients aged 9 years and older
Officials with the FDA have approved minocycline (Amzeeq, Foamix) topical foam, 4% for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in adults and pediatric patients aged 9 years and older, according to a company press release.
Formerly known as FMX101, Amzeeq is the first topical minocycline to be approved by the FDA for any condition.
Minocycline, a broad-spectrum antibiotic, is known for its efficacy in treating moderate-to-severe acne. However, its use is limited in some patients due to systemic adverse effects when taken orally and it has not been available as a topical treatment until now, according to Foamix.
Foamix’s Molecule Stabilizing Technology (MST) platform was used to effectively deliver minocycline in a foam-based vehicle, according to the release.
“Our innovative MST technology allowed us to develop a topical formulation of minocycline in a convenient- once-daily treatment regimen that maintains the stability of the active ingredient while delivering it into the skin,” Iain Stuart, PhD, chief scientific officer of Foamix, said in a statement. “The approval of Amzeeq represents a significant step toward our goal of enhancing the standard of care for millions of acne sufferers in the US who deserve alternatives in treatment.”
The approval is based on data from 3 phase 3 clinical trials in 2418 patients who were 9 years of age and older. For the 12-week study, patients with moderate-to-severe acne vulgaris were treated once-daily with minocycline or vehicle. Patients were not allowed to use any other topical or systemic acne medications during this time.
Overall, the data showed a statistically significant disease improvement with topical minocycline treatment compared with vehicle for the co-primary endpoint of absolute reduction of inflammatory lesions. The other 2 studies demonstrated a statistically significant improvement in IGA treatment success, which was defined as a score of 0 (clear) or 1 (almost clear) and at least a 2-point decrease from baseline.
Regarding safety, minocycline was well-tolerated and no treatment-related serious adverse events were reported in the study. The most common adverse effect was headache, which was reported in 3% of patients treated with minocycline versus 2% of patients treated with vehicle.
Foamix expects Amzeeq to be available for prescribing in January 2020, according to the release.
Foamix Receives FDA Approval of Amzeeq Topical Minocycline Treatment for Millions of Moderate to Severe Acne Sufferers [news release]. Foamix. http://www.foamix.com/news-releases/news-release-details/update-foamix-receives-fda-approval-amzeeqtm-topical-minocycline. Accessed October 21, 2019.