Topical minocycline foam safe, effective for papulopustular rosacea in phase 3 studies
FMX103 1.5%, a topical minocycline foam, was found to be efficacious with an adequate safety profile for moderate to severe papulopustular rosacea, according to a study published in Journal of the American Academy of Dermatology.
“When it comes to treating rosacea, there have been very few new treatment developments in recent years,” Iain Stuart, PhD, chief scientific officer at Foamix Pharmaceuticals, told Healio. “The study results move forward the possibility of a new, innovative topical medication for moderate to severe papulopustular rosacea to market that would help to address an unmet need for both patients and dermatology health care professionals.”
Two identical 12-week randomized, multicenter, double-blind, vehicle-controlled, two-arm phase 3 studies were conducted at 100 study locations in the United States. Participants were randomly assigned 2:1 to receive either FMX103 1.5% minocycline foam or vehicle foam. Treatments were applied once daily for 12 weeks at approximately the same time each day.
Study FX2016-11 (study 11) enrolled 751 subjects (FMX103, n = 495; vehicle foam, n = 256), and study FX2016-12 (study 12) enrolled 771 subjects (FMX103, n = 514; vehicle foam, n = 257) with moderate to severe papulopustular rosacea.
At week 12, FMX103 was associated with statistically significant reductions in the absolute inflammatory lesion count from baseline, compared with the vehicle foam (study 11, P = .0031; study 12, P < .0001) and was superior to vehicle foam in meeting the Investigator Global Assessment (IGA) treatment success endpoint (study 11, P = .0273; study 12, P = .0077). The proportion of subjects achieving dichotomized IGA endpoint success at week 12 for FMX103 was superior compared with vehicle foam for study 11 (P = .0171) and study 12 (P = .0189).
The daily application of FMX103 for 12 weeks was safe and well tolerated with no serious treatment-emergent adverse events. Of the 1,008 subjects who received at least one dose of FMX103, more than 95% reported no or mild skin tolerability issues, such as burning/stinging, flushing/blushing, dryness, itching, peeling or hyperpigmentation.
“Both studies demonstrated high statistically significant superiority of FMX103 compared with the vehicle in both primary endpoints of absolute inflammatory lesion reduction and IGA treatment success at week 12,” Stuart said. “Paired with the finding that patients were no more likely to experience treatment-emergent adverse events from FMX103 than from vehicle treatment, we see the results as a big step forward in bringing a new topical papulopustular rosacea treatment to market.” – by Erin T. Welsh