Allergan, Paratek Report Positive Results From Two Phase 3 Trials Of Sarecycline

(RTTNews) - 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.