FMX 101 filed with FDA for acne.- Foamix Pharma.

Foamix Pharmaceuticals announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval for FMX 101 for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older.

The NDA submission is supported by the previously communicated results from two Phase III trials, FX2014-05 and FX2017-22. In these trials, FMX 101 met both co-primary endpoints, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment (IGA) treatment success. In these trials, the safety profile of FMX 101 was generally favorable and consistent throughout the clinical development program. The NDA submission also incorporates information on chemistry manufacturing and controls, and data from non-clinical toxicology studies on FMX 101.