LB938 Efficacy of FMX101 4% topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Integrated summary from three phase 3 studies
Del Rosso J, Stein Gold LF, Weiss J, Green L, Stakias V, and Stuart I. LB938 Efficacy of FMX101 4% topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Integrated summary from three phase 3 studies. Journal of Investigative Dermatology 2020; 140(7):B9.
Journal of Investigative Dermatology
Background: FMX101 4% is a novel FDA-approved minocycline-containing topical foam for the treatment for acne vulgaris.
Objective: Compare the efficacy of FMX101 4% vs vehicle foam for acne based on the integrated analysis of 3 Phase 3 studies.
Methods: In 3 multicenter, randomized, double-blind, Phase 3 studies (FX2014-04, N=466; FX2014-05, N=495; FX2017-22, N=1488), FMX101 4% was compared to vehicle in subjects with moderate-to-severe acne. Subjects applied the study drug once daily for 12 weeks. The co-primary efficacy endpoints were the absolute change from baseline at week 12 in inflammatory lesions and the proportion of subjects with Investigator Global Assessment (IGA) treatment success. Percent change from baseline at week 12 in noninflammatory lesions was a secondary endpoint.
Results: The integrated population included 2449 subjects (FMX101 4%, n=1378; vehicle, n=1071). FMX101 4% demonstrated statistically significant benefit vs vehicle for both co-primary endpoints. There was a significantly greater reduction in inflammatory lesions from baseline at week 12 in the FMX101 4% group compared to vehicle (P<.0001), and a significantly greater percent of FMX101 4% subjects who achieved IGA treatment success at week 12 compared to vehicle (P<.0001). The effect of FMX101 4% was observed as early as week 3, and was maintained throughout the 12-week trial. There was a significantly (P=.0019) greater percent reduction in noninflammatory lesions at week 12 in the FMX101 4% group vs vehicle.
Conclusions: FMX101 4% demonstrated statistically significant benefits compared to vehicle in treating moderate-to-severe acne vulgaris in the pooled population of 3 Phase 3 studies.