13509 Integrated safety analysis of FMX103 1.5% topical minocycline foam for the treatment of moderate to severe papulopustular rosacea: Results from two phase 3 studies
Gold LS, Del Rosso JQ, Kircik L, Bhatia N, Hooper D, and Nahm WK. 13509 Integrated safety analysis of FMX103 1.5% topical minocycline foam for the treatment of moderate to severe papulopustular rosacea: Results from two phase 3 studies. Journal of the American Academy of Dermatology 2020; 83(6):AB119.
Journal of the American Academy of Dermatology
Objective: To evaluate the safety of FMX103 1.5% topical minocycline foam for adults with moderate to severe papulopustular rosacea, using pooled data from 2 phase 3 studies.
Methods: Two phase 3 randomized, multicenter, double-blind, vehicle-controlled, 2-arm, 12-week studies (FX2016-11 and FX2016-12) evaluated efficacy, safety, and tolerability of FMX103 vs vehicle foam. Eligible subjects (based on lesion count and IGA score for rosacea severity) were randomly assigned in a 2:1 ratio (FMX103: vehicle). Subjects returned for visits at weeks 2, 4, 8, and 12.
Results: The safety population included 1521 subjects (FMX103, n = 1008; vehicle, n = 513). Treatment emergent adverse events (TEAEs) were experienced by 341 subjects (22.4%), with the incidence balanced between treatment groups (FMX103, 21.7%; vehicle, 23.8%). The most frequently reported TEAEs, in the FMX103 and vehicle groups, respectively, were viral upper respiratory tract infection (2.4% vs 2.3%) and upper respiratory tract infection (1.9% vs 2.5%). Most TEAEs were mild or moderate in severity (FMX103, 98.6%; vehicle, 96.7%). Serious TEAEs were reported in 8 subjects (FMX103, n = 3, 0.3%; vehicle, n = 5, 1.0%); all were unrelated to treatment. TEAEs leading to drug withdrawal occurred in 9 subjects (FMX103, n = 7, 0.7%; vehicle, n = 2, 0.4%); 1 TEAE was considered to be related to FMX103 (moderate pruritus). At week 12, all facial tolerability assessments in both groups had higher percentages of subjects reporting “none” compared with baseline and the assessments trended toward improving scores.
Conclusions: This integrated safety analysis demonstrated that FMX103 1.5% is well tolerated, with a favorable safety profile.