FDA Accepts New Drug Application for Rosacea Treatment Topical Foam

October 17, 2019
Kenny Walter

Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

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.