The FDA set a 2020 PDUFA action date for FMX103, a topical foam to treat papulopustular rosacea.
The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for FMX103 (minocycline topical foam 1.5%), a topical foam to treat moderate-to-severe papulopustular rosacea in adults.
The FDA set June 2, 2020 as the Prescription Drug User Fee Act (PDUFA) action date for the topical foam developed by Foamix Pharmaceuticals.
"The application includes what we believe is a strong and complete clinical data package,” David Domzalski, Chief Executive Officer of Foamix, said in a statement. “Rosacea is a challenging condition to treat for patients and healthcare providers. If approved, FMX103 has the potential to address significant unmet needs for those who are burdened with rosacea.”
The new application comes on the heels of a pair of 12-week double-blind phase III efficacy and safety trials—FX2016-11 and FX2016-12—as well as a 40-week open-label safety extension trial—FX2016-13.
All 3 studies met both co-primary endpoints in demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment (IGA) treatment success.
The investigators reported no treatment-related serious adverse events in the FMX103 clinical development program, where the most common adverse event was an upper respiratory tract infection.
The NDA submission incorporates information from phase I and phase II trials, as well as chemistry manufacturing and controls and data from nonclinical toxicology studies.