Phase III studies FX2016-11 and FX2016-12 of FMX 103 for rosacea published in Journal of the American Academy of Dermatology.- Foamix Pharma

Foamix Pharmaceuticals announced the publication of the Company's Phase III studies FX2016-11 and FX2016-12 (Studies 11 & 12) of FMX 103 (minocycline, 1.5% foam) for moderate to severe papulopustular rosacea in the Journal of the American Academy of Dermatology (JAAD). Studies 11 and 12 were conducted by Foamix to support the New Drug Application (NDA) submission of FMX103 (minocycline, 1.5% foam), which is currently under review by the FDA for the treatment of moderate to severe papulopustular rosacea in adults. Both studies demonstrated high statistically significant superiority of FMX103 compared with vehicle in both primary endpoints of absolute inflammatory lesion reduction and Investigator's Global Assessment (IGA) treatment success at Week 12 where approximately half of subjects achieved treatment success as defined by the latter endpoint. There was a statistically significant reduction in inflammatory lesions versus vehicle as early as Week 4 of treatment, and all subsequently assessed timepoints throughout the entire treatment course of the study. Subjects were no more likely to experience treatment-emergent adverse events (TEAEs) from FMX103 than from vehicle treatment. The majority of TEAEs were mild to moderate. More than 95% of subjects using FMX103 had skin tolerability scores of none or mild at the treatment application site at Week 12. Specifically for erythema as part of skin tolerability assessments, 5.5% and 6.6% of subjects who received FMX103 in Studies 11 and 12 respectively, were assessed as being clear or almost clear at Baseline. At Week 12, 40.9% and 48.3% of subjects who received FMX103 respectively were assessed as clear or almost clear of erythema.See: "Minocycline 1.5% Foam for the Topical Treatment of Moderate-to-Severe Papulopustular Rosacea: Results of Two Phase 3, Randomized, Clinical Trials." Linda Stein Gold et al. Journal of the American Academy of Dermatology Published online: January 28, 2020 DOI: https://doi.org/10.1016/j.jaad.2020.01.043