NDA for Investigational Rosacea Treatment Submitted to FDA

Foamix Pharmaceuticals has submitted a New Drug Application (NDA) for FMX103, an investigational treatment for moderate to severe papulopustular rosacea in patients ≥18 years old.

FMX103 is a topical foam formulation of minocycline. The NDA submission includes data from two phase 3 trials in which the efficacy and safety of the minocycline foam 1.5% was evaluated for 12 weeks for the treatment of moderate to severe facial papulopustular rosacea. 

Results showed that both studies met the co-primary end points (absolute change from baseline in inflammatory lesion count at Week 12, and Investigator Global Assessment treatment success at Week 12) indicating statistically significant improvement with FMX103 compared with vehicle foam. In addition, findings from a long-term safety extension trial showed that the treatment was generally well-tolerated; upper respiratory tract infection (3.8%) was the most frequently reported non-cutaneous adverse event, while contact dermatitis (1.0%) was the most frequently reported cutaneous adverse event. 

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“It can be challenging for patients with papulopustular rosacea to find therapies that provide meaningful symptom relief and are also well tolerated when applied to their skin,” said David Domzalski, Chief Executive Officer. “Building on the impressive phase 3 FMX103 topline results announced in November last year, we are excited to have reached this NDA submission milestone earlier than previously anticipated.”

For more information visit Foamix.com.