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FDA Approves New Topical Rosacea Therapy

The FDA has approved minocycline topical 1.5% foam (Zilxi) for the treatment of inflammatory lesions associated with rosacea in adults. “This approval is welcome news for clinicians and patients who seek novel options for this difficult to treat skin disorder,” said David Domzalski, chief executive officer of Menlo.

Approval of minocycline topical 1.5% foam was based on data from 2 clinical, randomized, double-blind, vehicle-controlled trials that included 1522 participants aged 18 years and older. Participants in both studies were treated for 12 weeks with either vehicle or minocycline topical 1.5% foam with no other additional medications. After 12 weeks of treatment, minocycline topical 1.5% foam showed statistically significant improvements in inflammatory lesion count and Investigator Global Assessment treatment success compared with vehicle, which met both co-primary efficacy endpoints.

The most common treatment-related adverse event was diarrhea, which occurred in 1% of participants. However, no serious treatment-related adverse events were reported.

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