Phase 3 trials for sarecycline meet primary endpoints

Allergan PLC and Parateks Pharmaceuticals' Phase 3 trials of sarecycline met their 12-week primary efficacy endpoints.
Sarecycline, a once-daily oral antibiotic, was created to treat patients with moderate to severe acne in the community setting.
"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," David Nicholson, chief global research and development officer at Allergan, in a statement. "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."
Allergan noted that, due to the results of the data, the company plans to file a New Drug Application (NDA) to the U.S. Food and Drug Administration this year.
"We are pleased with the results of the sarecycline Phase 3 program and Allergan's intention to move ahead with an NDA submission for approval in the U.S. by the end of 2017," Dr. Evan Loh, president and chief medical officer of Paratek, said.  "Sarecycline is a narrow spectrum antibiotic, which we believe can offer meaningful clinical benefits for patients afflicted with acne."