WASHINGTON (dpa-AFX) - Allergan plc (AGN) and Paratek Pharmaceuticals Inc. (PRTK) announced that two Phase 3 trials of sarecycline for the treatment of moderate to severe acne met their 12 week primary efficacy endpoints. Sarecycline is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting. Based on these data, Allergan plans to file a New Drug Application to the U.S. Food & Drug Administration in the second half of this year.
'The positive efficacy results observed in the pivotal phase 3 clinical trials indicate that sarecycline can be an effective treatment option for patients with moderate to severe acne.' said David Nicholson, Chief Global Research & Development Officer at Allergan. 'We look forward to submitting a new drug application for sarecycline and bringing to market a potential new option for physicians treating patients with acne.'
Both SC1401 & SC1402 were designed to be replicative phase 3 randomized, multicenter, double-blind, placebo-controlled studies to evaluate the efficacy and safety of 1.5 mg/kg per day of sarecycline compared to placebo in the treatment of moderate to severe acne.
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