October 21, 2019
The US Food and Drug Administration (FDA) has approved 4% minocycline topical foam (Amzeeq, Foamix Pharmaceuticals) to treat inflammatory lesions of nonnodular moderate to severe acne vulgaris in adults and in children aged 9 years or older.
It's the first topical minocycline formulation approved by the FDA, the company notes in a news release announcing approval.
Until now, minocycline has not been available as a topical medication, owing to its instability in traditional topical formulations, the company explains. Amzeeq utilizes the company's proprietary molecule-stabilizing technology platform to effectively deliver minocycline in a foam-based vehicle, the company says. It is applied once daily.
Minocycline topical foam was evaluated in three 12-week, multicenter, randomized, double-blind, vehicle-controlled phase 3 studies that involved 2418 patients aged 9 years or older who had moderate to severe acne vulgaris.
All three studies showed statistically significant improvement in acne with topical minocycline vs vehicle for the coprimary endpoint of absolute reduction of inflammatory lesions. Two studies showed statistically significant improvement in Investigator Global Assessment (IGA) treatment success ? defined as a score of 0 ("clear") or 1 ("almost clear") and at least a 2-point decrease from baseline on the IGA scale.
Minocycline topical foam was well tolerated; no treatment-related serious adverse events were reported. The most common adverse reaction was headache, reported in 3% of patients who were treated with minocycline foam, vs 2% of patients who were treated with vehicle.
Topical minocycline provides a "much-needed option in the treatment of moderate to severe acne," Linda Stein Gold, MD, director of dermatology clinical research and head of dermatology at Henry Ford Health System in Detroit, Michigan, said in the news release.
"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," she added.
The company expects minocycline topical foam to be available in January 2020.