The Food and Drug Administration (FDA) has approved Zilxi™ (minocycline; Menlo Therapeutics) topical foam 1.5% for the treatment of inflammatory lesions of rosacea in adults.

Zilxi uses the Company’s proprietary platform to deliver minocycline, a tetracycline-class drug, in a foam formulation. The approval was supported by data from two 12-week, multicenter, double-blind, vehicle-controlled phase 3 trials (Trial 1 and Trial 2) that evaluated the efficacy and safety of Zilxi in 1522 patients aged ≥18 years with moderate to severe facial papulopustular rosacea. Patients were randomized 2:1 to receive either Zilxi once daily or vehicle, and were not permitted to use other topical or systemic medications to treat inflammatory lesions of rosacea during the trials. 

Results showed that both studies met the co-primary end points (absolute change from baseline in inflammatory lesion count at Week 12 and Investigator Global Assessment treatment success at Week 12), achieving statistically significant improvements with Zilxi compared with vehicle. In a combined analysis of both studies, Zilxi was associated with a significantly greater reduction of inflammatory lesion counts at week 12 vs vehicle (-18.0 vs -14.9, respectively; P <.001). Moreover, a greater proportion of patients treated with Zilxi achieved IGA treatment success of 0 (clear) or 1 (almost clear) at week 12 compared with vehicle (50.6% vs 41.0%, respectively; P <.001).

With regard to safety, Zilxi was well tolerated with the most commonly reported adverse reaction (≥1%) being diarrhea.

“This is the only product containing minocycline approved by the FDA for rosacea,” said Iain Stuart, PhD, Chief Scientific Officer of Menlo. “The availability of a novel topical formulation of this molecule underscores our efforts to provide innovative treatment options for patients who suffer from difficult to treat skin conditions.”

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The Company expects Zilxi to be available in 4th quarter of 2020. The product will be supplied in a 30-gram aerosol container. Each gram of Zilxi contains 15mg of minocycline equivalent to 16mg of minocycline hydrochloride.

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