Monday, March 30, 2020

Monday, March 30, 2020

FDA approves first topical minocycline for acne treatment


http://www.foamix.com

The U.S. Food and Drug Administration (FDA) has approved AMZEEQTM (minocycline) topical foam, 4 percent. Manufactured by Foamix Pharmaceuticals Ltd., AMZEEQ, formerly known as FMX101, is the first topical minocycline to be approved by the FDA for any condition.

AMZEEQTM is indicated for the treatment of inflammatory lesions of non-nodular, moderate to severe acne vulgaris in adults and children who are 9 years of age and older.

Minocycline’s use is limited in some patients due to systemic side effects when taken orally. Prior to Foamix’s proprietary Molecule Stabilizing Technology (MST) platform, which effectively delivers minocycline in a foam-based vehicle, minocycline was not available as a topical treatment due to its instability in traditional topical formulations.

"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, Ph.D., chief scientific officer of Foamix, said in a press release. "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."

Foamix plans to introduce AMZEEQ to the market in January.

Organizations in this Story

Foamix Pharmaceuticals Ltd.

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