Foamix Submits New Drug Application to U.S. FDA for FMX103 for the Treatment of Moderate-to-Severe Papulopustular Rosacea
Rosacea is a common skin condition that causes redness and visible blood vessels in the face. It may also produce small, red, pus-filled bumps. These signs and symptoms may flare up for a period of weeks to months and then diminish for a while. Rosacea can be mistaken for acne, an allergic reaction or other skin problems. There are approximately 16 million U.S. rosacea sufferers (source: Aimee Two, MD, et al, JAAD, Volume 72, Issue 5,
“It can be challenging for patients with papulopustular rosacea to find therapies that provide meaningful symptom relief and are also well tolerated when applied to their skin,” said
The NDA submission is supported by the previously communicated results from two Phase 3 clinical trials, FX2016-11 and FX2016-12. In these trials, FMX103 achieved both co-primary endpoints, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment (IGA) treatment success. In both trials, and in the long-term safety extension study FX2016-13, the safety profile of FMX103 was shown to be 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.
“Our goal with developing FMX103 is to provide patients with an efficacious and well-tolerated treatment in a convenient topical foam formulation,” stated
Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical therapies to treat dermatological diseases. Our leading clinical stage product candidates are FMX101 and FCD105 which are intended for the treatment of moderate-to-severe acne vulgaris and FMX103 which is intended for the treatment of papulopustular rosacea. We continue to pursue research & development of our proprietary, innovative topical delivery technologies for the treatment of various skin conditions. We currently have development and license agreements relating to our technology with various pharmaceutical companies including LEO Pharma A/S and others.
Foamix uses its website (www.Foamix.com) 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 future development plans of FMX103. All statements other than statements of historical facts are forward-looking statements. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, determination by the
Ilan Hadar, CFO & Country Manager
Foamix Pharmaceuticals Ltd.
|U.S. Investor Relations
LifeSci Advisors, LLC
Source: Foamix, Ltd.