FDA approves topical foam for rosacea in adults

The FDA today approved a topical foam for the treatment of inflammatory lesions of rosacea in adults, according to a company press release.

Minocycline topical foam 1.5% (Zilxi, Menlo Therapeutics) was developed as FMX103 by Menlo’s wholly-owned subsidiary Foamix Pharmaceuticals Ltd., and is the first minocycline product to be approved by the FDA for use in rosacea.

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

Rosacea is a diverse skin condition that most commonly presents with symptoms such as deep facial redness, telangiectasia and acne-like inflammatory lesions.

Menlo leveraged its proprietary Molecule Stabilizing Technology platform to deliver minocycline in a foam-based vehicle, according to the company.

“This is the only product containing minocycline approved by the FDA for rosacea,” Iain Stuart, PhD, Chief Scientific Officer of Menlo, said in the release. “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 in part on data from two randomized clinical trials involving 1,522 adults with inflammatory lesions of rosacea who were assigned the minocycline topical foam or placebo once daily for 12 weeks. The co-primary efficacy endpoints were absolute change from baseline in inflammatory lesion counts at week 12 and the proportion of participants with treatment success at week 12, defined as an Investor Global Assessment score of 0 (“clear”) or 1 (“almost clear”), and at least a two-grade decrease from baseline at week 12. Minocycline topical foam met both co-primary endpoints in each clinical trial, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment treatment success. No treatment-related serious adverse events were reported.

The most common adverse reaction reported by less than 1% of participants was diarrhea.

Minocycline topical foam will likely be available by the fourth quarter of this year, according to Menlo. – by Regina Schaffer