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VYNE Therapeutics Announces Publication of Long-term Safety & Efficacy Data for ZILXI™ (minocycline) topical foam, 1.5% in the Journal of Clinical and Aesthetic Dermatology
ZILXI is the First FDA Approved Minocycline Product for the Treatment of Inflammatory Lesions of Rosacea in AdultsZILXI demonstrated a favorable safety and
About this update from Vyne Therapeutics Inc.
[{"type":"text","content":"ZILXI is the First FDA Approved Minocycline Product for the Treatment of Inflammatory Lesions of Rosacea in AdultsZILXI demonstrated a favorable safety and tolerability profile for up to 52 weeks of treatmentEfficacy of ZILXI continued to develop for an additional 40 weeks of treatment after an initial treatment period of 12 weeks\n BRIDGEWATER, N.J., Dec. 01, 2020 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) announced today the peer reviewed publication of long-term safety and efficacy data for ZILXI™ (minocycline) topical foam, 1.5% in the Journal of Clinical and Aesthetic Dermatology (JCAD). Study FX2016-13 evaluated the safety and efficacy of ZILXI for up to 40 weeks of open-label treatment immediately following an initial 12-week double-blind treatment. This study was conducted by VYNE to support the New Drug Application (NDA) of ZILXI which was approved by the U.S. Food and Drug Administration (FDA) for the treatment of inflammatory lesions of rosacea in adults in May of this year. “Following the commercial launch of ZILXI in October, we are pleased that JCAD has accepted these long-term safety and efficacy data for publication,” said David Domzalski, CEO of VYNE. “We hope that ZILXI’s safety profile for long term treatment coupled with enduring efficacy will provide patients living with rosacea an attractive new option for lasting control of their disease.” Highlights from the Long-Term Safety & Efficacy in Study FX2016-13: Study FX2016-13 included a total of 504 patients in the all-treated population, all of whom had completed 12 weeks of ZILXI or vehicle treatment in one of two preceding double-blind phase 3 studies (Studies FX2016-11 or FX2016-12). Patients continued for up to an additional 40 weeks of open-label treatment with ZILXI. 410 patients completed participation in the study of which 332 patients had received a total of 52 weeks of ZILXI therapy which was in excess of the subject sample size requirements specified in the regulatory guidance for this type of safety evaluation (ICH E1A, 1995). 96.1% of patients participating in study FX2016-13 received a minimum of 26 weeks of ZILXI therapy. Key findings from the study are as follows: Non-dermal adverse events were comparable in type and frequency with those reported during the preceding 12-week double-blind studies. The mo...