Foamix Announces FDA Acceptance of New Drug Application for FMX101 Minocycline Foam to Treat Moderate-to-Severe Acne

Foamix Pharmaceuticals (NASDAQ:FOMX) has announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for FMX101 for review.

As quoted in the press release:

Foamix is seeking approval of FMX101 for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients nine years of age and older.  The FDA has set October 20^th, 2019 as the Prescription Drug User Fee Act (PDUFA) action date.

“The acceptance of this NDA is an important step toward potentially making FMX101 available to patients and we look forward to working with the FDA during this review process,” said David Domzalski, Chief Executive Officer. “The application incorporates what we believe to be a very strong clinical data package. If approved, FMX101 has the potential to address a significant unmet need in the treatment of moderate-to-severe acne, which remains a difficult to treat condition.”

The NDA is supported by the previously communicated results from two Phase 3 trials, FX2014-05 and FX2017-22. In these trials, FMX101 met both co-primary endpoints, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment (IGA) treatment success. No treatment-related serious adverse events have been identified in the FMX101 clinical development program, whereas the most common adverse event was upper respiratory tract infection.  The NDA submission also incorporates information on chemistry manufacturing and controls, and data from non-clinical toxicology studies on FMX101.

Click here to read the full press release.