Allergan plc and Paratek Pharmaceuticals Inc. 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 (NDA) to the U.S. Food & Drug Administration (FDA) 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."