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# Allergan NDA Planned for Acne Drug
- URL: https://www.fdaweb.com/allergan-nda-planned-for-acne-drug/
- Published: 2017-03-27T12:00:00.000Z
- Updated: 2026-09-14T22:13:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138307

Allergan says it will file an NDA in the second half of this year after announcing data from two Phase 3 trials of sarecycline for treating 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, the company says. Both SC1401 and SC1402 trials 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 treating acne. “Sarecycline was statistically significantly (p < 0.004) superior to placebo with respect to primary efficacy endpoints,” it says.