The FDA has approved Zilxi™ (minocycline) topical foam, 1.5%, from Menlo Therapeutics for the treatment of inflammatory lesions of rosacea in adults. Zilxi, developed as FMX103 by Menlo’s wholly-owned subsidiary Foamix Pharmaceuticals Ltd., is the first minocycline product of any kind to be approved by the FDA for use in rosacea.
Zilxi is formulated with Menlo’s proprietary Molecule Stabilizing Technology (MST™) platform to effectively deliver minocycline in a foam-based vehicle. Menlo expects to have Zilxi available for prescribing by the fourth quarter.
“This approval is welcome news for clinicians and patients who seek novel options for this difficult to treat skin disorder,” says David Domzalski, Chief Executive Officer of Menlo. “Zilxi is a potential turning point in rosacea treatment, providing millions of people with a new treatment option that is well-tolerated and effective.”
FDA approval is primarily supported by data from two clinical trials in 1,522 patients 18 years of age and older. In each 12-week multicenter, randomized, double-blind, vehicle-controlled trial, subjects with inflammatory lesions of rosacea were treated once daily with Zilxi or vehicle. No other topical or systemic medication affecting the course of inflammatory lesions of rosacea was permitted for use during these trials. The co-primary efficacy endpoints were (a) the absolute change from baseline in inflammatory lesion counts at Week 12 and (b) the proportion of subjects with treatment success at Week 12 defined as an IGA score of 0 (“clear”) or 1 (“almost clear”), and at least a two-grade improvement (decrease) from baseline at Week 12.
Zilxi met both co-primary endpoints in each clinical trial, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment (IGA) treatment success. No treatment-related serious adverse events were reported. The most common adverse reaction reported by ≥1% of subjects treated with Zilxi and more frequently than in subjects treated with vehicle was diarrhea (1% vs. 0%), respectively.