Open-label Extension Study Evaluating Long-term Safety and Efficacy of FMX101 4% Minocycline Foam for Moderate-to-Severe Acne Vulgaris.

This study sought to evaluate the long-term safety and efficacy of FMX101 4% topical minocycline foam for the treatment of moderate-to-severe acne. This was an open-label extension of two double-blind studies, Study 04 and Study 05. Subjects were enrolled at 35 sites in the United States and one site in the Dominican Republic. Eligible subjects who completed 12 weeks of double-blind treatment with FMX101 4% or vehicle in those studies could continue for an additional nine months of open-label treatment with FMX101 4%. Eligibility required an Investigator's Global Assessment (IGA) score that had not worsened when compared to baseline at the 12-week visit. Safety, efficacy, and satisfaction assessments were performed. Of the 961 subjects enrolled in Study 04 (n=466) and Study 05 (n=495), 657 subjects entered the open-label phase (Study 04: n=284; Study 05: n=373), with 414 subjects completing the study (Study 04, n=172; Study 05, n = 242). Treatment-emergent adverse events (TEAEs) were similar to those in the double-blind studies. No serious TEAEs led to subject discontinuation. At Week 52, for facial tolerability assessment, over 95 percent of subjects had no or only mild signs and symptoms. Through Week 52, there were ongoing reductions in inflammatory lesions and increasing IGA treatment success. FMX101 4% minocycline foam appeared to be safe, effective, and well-tolerated for up to 52 weeks in the treatment of moderate-to-severe acne.