Foamix Pharmaceuticals has announced the completion of enrollment in a Phase 2 clinical trial of FMX103, a minocycline foam for the treatment of papulopustular rosacea.
In this Phase 2 double-blind, randomized, placebo-controlled trial, 233 patients have been enrolled in 18 sites throughout Germany. Patients were randomized to receive FMX103 (3% minocycline foam), FMX103 (1.5% minocycline foam) or vehicle foam over 12 weeks, followed by a four-week post-treatment evaluation. Primary endpoints are safety, tolerability and efficacy in the treatment of moderate-to-severe papulopustular rosacea. Foamix expects to report results from this study by the end of the year and to develop FMX103 in the U.S. under the FDA’s 505(b)(2) regulatory pathway.
“We are pleased to have reached full enrollment of our Phase 2 study earlier than we originally anticipated,” said Dov Tamarkin, PhD, CEO of Foamix Pharmaceuticals. “There is a significant unmet need for safe and effective alternatives for the treatment of rosacea. We believe FMX103 has the potential to offer meaningful benefits over the current standard of care, and we look forward to receiving the results of this study later this year.”