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ARTICLE | Clinical News

Foamix planning NDA for minocycline foam to treat rosacea

November 7, 2018 11:00 AM UTC

Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX) plans to submit an NDA to FDA next year for FMX103 to treat moderate to severe papulopustular rosacea after the product met the co-primary endpoints in a pair of Phase III trials in the indication. FMX103 is a topical 1.5% foam formulation of minocycline, a semisynthetic derivative of tetracycline.

The double-blind, U.S. FX2016-11 and FX2016-12 trials enrolled 751 and 771 patients, respectively, to receive once-daily FMX103 or vehicle foam for 12 weeks. On the first co-primary endpoint in FX2016-11, FMX103 significantly reduced mean inflammatory lesion count from baseline to week 12 by 17.57 lesions vs. 15.65 lesions for vehicle (p=0.0031). On the other co-primary endpoint, 52.1% of patients who received FMX103 achieved an Investigator’s Global Assessment (IGA) score of 0 or 1 with a ≥2-grade improvement from baseline to week 12 vs. 43% of patients who received vehicle (p=0.027)...

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