Two phase 3 studies of Foamix Pharmaceuticals’ FMX103 (minocycline, 1.5% foam) were published in the Journal of the American Academy of Dermatology (online January 26). Foamix conducted FX2016-11 and FX2016-12 (Studies 11 & 12) to support the New Drug Application (NDA) submission of FMX103, which is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe papulopustular rosacea in adults.
Both studies demonstrated high statistically significant superiority of FMX103 compared with vehicle in both primary endpoints of absolute inflammatory lesion reduction and Investigator's Global Assessment (IGA) treatment success at Week 12 where approximately half of subjects achieved treatment success as defined by the latter endpoint. There was a statistically significant reduction in inflammatory lesions versus vehicle as early as Week 4 of treatment, and all subsequently assessed time points throughout the entire treatment course of the study.
The majority of treatment-emergent adverse events (TEAEs) were mild to moderate, and subjects were no more likely to experience TEAEs from FMX103 than from vehicle treatment. More than 95 percent of subjects using FMX103 had skin tolerability scores of none or mild at the treatment application site at Week 12.
In terms of erythema, 5.5 percent and 6.6 percent of subjects who received FMX103 in Studies 11 and 12 respectively, were assessed as being clear or almost clear at baseline. At Week 12, 40.9 percent and 48.3 percent of subjects who received FMX103 respectively were assessed as clear or almost clear of erythema.
“The publication of these data represents another step forward in our efforts to bring an innovative, topical medication to market for moderate-to-severe papulopustular rosacea, which can be challenging to treat and represents an unmet need in dermatology with few new treatment developments in recent years,” said Dr. Iain Stuart, chief scientific officer of Foamix. “We are proud that JAAD has accepted studies FX2016-11 and FX2016-12 (Studies 11 & 12) for publication, ensuring that a broad range of dermatology healthcare professionals globally will have access to these important data.”