Foamix Announces FDA Acceptance of its New Drug Application for FMX103 Minocycline Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea
“The FDA’s acceptance of the FMX103 NDA is another important milestone for Foamix as the company evolves into a fully integrated pharmaceutical company with clinical, development, and commercial capabilities. We look forward to working closely with the FDA throughout the review process," said
The NDA submission is supported by the previously communicated results from two 12-week double-blind Phase 3 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, 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 FMX103 clinical development program, where the most common adverse event was upper respiratory tract infection. The NDA submission also incorporates information from Phase 1 and Phase 2 clinical trials, chemistry manufacturing and controls, and data from nonclinical toxicology studies.
Foamix is a late clinical-stage specialty pharmaceutical company working to solve some of today’s most difficult therapeutic challenges in dermatology and beyond.
With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize solutions that were long thought impossible, including the world’s first topical minocycline foam. Its proprietary Molecule Stabilizing Technology (MST™) is utilized in the Company’s dermatology products in late stage development: FMX101 for the potential treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older, and FMX103 for the potential treatment of moderate-to-severe papulopustular rosacea in adults.
Foamix is a different type of specialty pharmaceutical company by design, driven to see the solutions, overcome barriers in all aspects of business, and reimagine what’s possible for conditions with high unmet needs.
Foamix uses its website as a channel to distribute information about Foamix and its product candidates from time to time. Foamix may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Foamix’s website in addition to following its press releases, filings with the
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the Company’s submission of a NDA for FMX103, its future development plans regarding FMX103, the PDUFA date of FMX103, the potential approval of FMX103 by the
Foamix Pharmaceuticals Ltd.
U.S. Investor Relations
LifeSci Advisors, LLC
Source: Foamix, Ltd.