Foamix Submits New Drug Application to U.S. FDA Seeking Approval of FMX101 in Treatment of Moderate-to-Severe Acne
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Foamix Submits New Drug Application to U.S. FDA Seeking Approval of FMX101 in Treatment of Moderate-to-Severe Acne
December 21, 2018 07:00 ET | Source: Foamix, Ltd.
REHOVOT, Israel and BRIDGEWATER, N.J., Dec. 21, 2018 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for FMX101 for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older.
“Submission of this NDA is yet another important milestone for Foamix, and potentially brings us one step further to commercial launch of FMX101,” commented David Domzalski, Chief Executive Officer. “We are making this submission following successful efficacy and safety outcomes in our Phase 3 program for FMX101 and incorporating guidance received from the FDA in a Type B pre-NDA meeting held earlier in 2018. We look forward to working with the Agency in its review of our application.”
The NDA submission 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. In these trials, the safety profile of FMX101 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 FMX101.
“The comprehensive body of clinical data we have generated with FMX101 suggest that it may offer patients an efficacious treatment in a convenient and well tolerated topical foam formulation,” stated Iain A. Stuart, Ph.D., Senior Vice President, Research & Development, Foamix. “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.”
