Foamix Pharmaceuticals bags AMZEEQ FDA approval for moderate to severe acne

AMZEEQ FDA approval : Israeli specialty pharma company Foamix Pharmaceuticals has bagged approval from the US Food and Drug Administration (FDA) for AMZEEQ (minocycline) topical foam, 4% for the treatment of moderate to severe acne.

Previously known as FMX101, AMZEEQ has been indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adult and pediatric patients, aged nine years of age and older. AMZEEQ is now the first topical minocycline to be approved by the US drug regulator for any condition.

A broad-spectrum antibiotic, Minocycline is known for its efficacy for the treatment of moderate to severe acne. However, its use is limited in certain patient populations because of systemic side effects when taken orally. Due to its instability in traditional topical formulations, minocycline has not been available as a topical treatment so far.

Foamix Pharmaceuticals said that it used its Molecule Stabilizing Technology (MST) platform for AMZEEQ to deliver minocycline effectively in a foam-based vehicle. AMZEEQ is expected to be launched as prescription medicine in January 2020.

Commenting on AMZEEQ FDA approval, David Domzalski – CEO of Foamix Pharmaceuticals, said: “The FDA approval of AMZEEQ is a milestone moment in dermatology and the most significant advancement with minocycline in almost 50 years.

“We are proud that our proprietary technology platform has led to this new treatment option, which we believe can help address unmet treatment needs for moderate to severe acne patients. We are looking forward to bringing AMZEEQ to market in January 2020, and to our Company’s first commercial launch.”

AMZEEQ FDA approval is backed by data recorded from three phase 3 clinical trials held across 2,418 patients of nine years of age or older with acne.

In each of the 12-week, multicenter, randomized, double-blind, vehicle-controlled trials, patients having moderate to severe acne vulgaris were treated daily once with AMZEEQ or vehicle. No other topical or systemic acne medication was allowed to be used by the patients during the study period.

All the three phase 3 acne clinical trials found statistically significant disease improvement with AMZEEQ compared to vehicle for the co-primary endpoint of absolute reduction of inflammatory lesions. In studies two and three, the broad-spectrum antibiotic showed a statistically significant improvement in IGA treatment success. IGA treatment success was defined as a score of 0, which is clear from achne or 1, which is almost clear and more than a two-point reduction from baseline.

Iain Stuart – Chief Scientific Officer of Foamix Pharmaceuticals, commenting on AMZEEQ FDA approval, said: “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.

“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.”

Recently, Foamix Pharmaceuticals filed a new drug application (NDA) for FMX103 to the FDA seeking FMX103 FDA approval for moderate-to-severe papulopustular rosacea in patients, aged 18 years and over.

For more pharma regulatory news like AMZEEQ FDA approval and other pharma industry news, keep following Pharma News Daily.