The United States Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) from Foamix Pharmaceuticals Ltd (Nasdaq: FOMX), a clinical stage specialty pharmaceutical company, for its FMX103 (minocycline topical foam 1.5%) topical foam, it was reported yesterday.

The company is seeking approval for FMX103 intended for the treatment of moderate-to-severe papulopustular rosacea in adults. The US FDA has set 2 June 2020 as the Prescription Drug User Fee Act action date.

The NDA submission is supported by the earlier communicated results from two 12-week double-blind Phase three efficacy and safety trials (Studies FX2016-11 and FX2016-12) and one 40-week open-label safety extension trial (Study FX2016-13). In Studies FX2016-11 and FX2016-12, FMX103 met both co-primary endpoints, showcasing statistically significant improvements in inflammatory lesion count and Investigator Global Assessment treatment success. No treatment-related serious adverse events have been identified in the FMX103 clinical development program, where the most common adverse event was upper respiratory tract infection. The NDA submission also includes information from Phase one and Phase two clinical trials, chemistry manufacturing and controls, and data from nonclinical toxicology studies.