FDA Approves Minocycline Topical Foam for Rosacea

The US Food and Drug Administration (FDA) has approved minocycline (Zilxi topical foam, 1.5%), the first every topical minocycline treatment for rosacea.

The announcement allows Menlo Therapeutics, a specialty pharmaceutical company focusing on the unmet needs in dermatology, to move forward with the treatment for inflammatory rosacea lesions in adults.

The new treatment is 1 of several broad-spectrum antibiotics called tetracyclines with anti-inflammatory properties. These drugs are used limitedly in some patients because of systemic side effects when taken orally.

However, the new topical foam can effectively and alternatively deliver minocycline.

"This is the only product containing minocycline approved by the FDA for rosacea," Iain Stuart, PhD, Chief Scientific Officer of Menlo, said in a statement. "The availability of a novel topical formulation of this molecule underscores our efforts to provide innovative treatment options for patients who suffer from difficult to treat skin conditions."

The approval is based on a pair of clinical trials involving 1522 adult patients. In each trial, investigators examined patients in a 12-week, multicenter, randomized, double-blind, vehicle-controlled trial.

The investigators sought co-primary endpoints of the absolute change from baseline in inflammatory lesion counts at week 12 and the proportion of subjects with treatment success at week 12 defined as an Investigator Global Assessment (IGA) score of 0 or 1, and at least a two-grade improvement from baseline to week 12.

The topical foam met both co-primary endpoints in each clinical trial, showing statistically significant improvements in inflammatory lesion counts and IGA scores.

Rosacea patients commonly suffer from a wide-range of symptoms, including deep facial redness, telangiectasia, and papules and pustules.

“This approval is welcome news for clinicians and patients who seek novel options for this difficult to treat skin disorder," David Domzalski, Chief Executive Officer of Menlo, said in a statement. "ZILXI is a potential turning point in rosacea treatment, providing millions of people with a new treatment option that is well-tolerated and effective."