The new topical minocycline 1.5% foam FMX103 from Foamix Pharmaceuticals appears effective against moderate-to-severe papulopustular rosacea, according to two randomized trials. "Treating rosacea can be challenging and there have been few new treatment developments in recent years," Dr. Iain Stuart of Foamix Pharmaceuticals, in Bridgewater, NJ, told Reuters Health by email. The two studies have been submitted to the US Food and Drug Administration as part of a new-drug application. Currently approved topical therapies include azelaic acid, metronidazole, and ivermectin, but these agents require continuous use to maintain their therapeutic effects, Dr. Stuart and colleagues note in the Journal of the American Academy of Dermatology. Oral antibiotics, specifically doxycycline and minocycline, are also frequently used but may have gastrointestinal and other side effects. To investigate whether FMX103 might provide relief without such side effects, the researchers conducted two identical randomized phase-3 12-week trials. In one, 495 subjects were randomized to receive FMX103 and 256 to the vehicle foam alone. In the other, 514 received FMX103 and 257 received vehicle foam alone. In both studies, statistically significant reductions from baseline in the number of inflammatory lesions were seen in the active-treatment groups in as little as four weeks and continued through to the end of treatment. In the first study, the improvement was 17.57 vs 15.65 (P=0.0031) and in the second, 18.54 vs 14.88 (P<0.0001). There were also significant improvements in Investigator Global Assessment (IGA) treatment-success scores. Earlier pharmacokinetic studies had shown that there were low plasma concentrations of minocycline over time and in the current study treatment-emergent adverse effect (TEAE) were mild to moderate, with the most common noncutaneous being viral upper-respiratory-tract infection and the most common cutaneous TEAE being pruritus. Only one patient discontinued due to a TEAE (pruritus). This resolved after discontinuation. "Both studies demonstrated high statistically significant superiority of FMX103 in both primary endpoints compared with the vehicle, seeing an absolute inflammatory lesion reduction and IGA treatment success at week 12, with patients no more likely to experience treatment-emergent adverse events with FMX103 than from vehicle," Dr. Stuart concluded. Dr. Robert T. Brodell, chair of dermatology at the University of Mississippi Medical Center, in Jackson, noted that the company's minocycline 4.0% foam (Amzeeq) is already available for treatment of acne. Rosacea, he added, "is commonly treated with metronidazole gel and more recently with topical ivermectin. It will be nice to have a new topical antibiotic for rosacea that has both antibiotic and anti-inflammatory effects." "The next step," said Dr. Brodell, who was not involved in the study, "is to compare this medication with other commonly used topical agents and even against systemic tetracycline antibiotics. Only then will we know how to best select patients for the various treatment options." Foamix Pharmaceuticals funded both trials. —David Douglas Source
