Foamix Pharmaceuticals Ltd. (FOMX), a clinical-stage pharmaceutical company that specializes in developing and commercializing proprietary topical therapies for dermatological conditions, announced today the peer review publication of the Phase 3 study FX2017-22 (“Study 22”) in the Journal of the American Academy of Dermatology(JAAD). Study 22 was conducted by Foamix to support the New Drug Application (NDA) submission of FMX101, which is currently under review by the FDA for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients nine years of age and older.
- The study showed high statistically significant superiority of FMX101 compared with vehicle in both primary endpoints of absolute inflammatory lesion reduction and IGA treatment success at week 12.
- FMX101 also met all secondary endpoints, showing statistically significant improvement in absolute reductions in both inflammatory lesions (papules, pustules and nodules) and non-inflammatory lesions (open and closed comedones).
- There was a statistically significant reduction in inflammatory lesions versus vehicle as early as week 3 of treatment, and all subsequently assessed timepoints throughout the entire treatment course of the study.
- Statistically, participants were no more likely to experience treatment-emergent adverse events (TEAEs) from FMX101 than from vehicle treatment. The majority of TEAEs were mild to moderate.
- More than 95% of participants using FMX101 had no or mild skin tolerability scores at the treatment application site at week 12.
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