FDA approves Seysara for treatment of moderate to severe acne

The Food and Drug Administration has approved sarecycline (Seysara) for the treatment of moderate to severe acne vulgaris for people aged 9 years and older, according to a press release from Paratek, the drug’s manufacturer.

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FDA approval is based on results from two phase 3 clinical trials (NCT02320149 and NCT02322866), in which patients received either sarecycline at 1.5 mg/kg per day or placebo for 12 weeks. Patients who received sarecycline were significantly more likely to reach the primary endpoint of improved acne severity based on absolute change in facial lesion counts and percentage of participants with Investigator Global Assessment success.

Common adverse events reported in the sarecycline group were nausea (3.2%), nasopharyngitis (2.8%), and headache (2.8%). The discontinuation rate due to adverse events among sarecycline-treated patients in both studies combined was 1.4%.

Sarecycline is an oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties, and is approved for once-daily use, according to Paratek. Seysara will be marketed in the United States by Almirall SA.

lfranki@mdedge.com