Sarecycline is a once-daily, oral and narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties to treat moderate to severe acne in the community setting.
Based on the current data, Allergan intends to submit a new drug application (NDA) with the US Food & Drug Administration (FDA) in the second half of this year.
The SC1401 and SC1402 are phase 3, randomized, multicenter, double-blind and placebo-controlled studies, which assessed the efficacy and safety of 1.5 mg/kg per day of sarecycline against placebo to treat moderate to severe acne.
The primary objective was the assessment of efficacy and safety of oral sarecycline 1.5 mg/kg per day compared against placebo to treat inflammatory acne lesions in subjects with moderate to severe acne based on investigators global assessment (IGA) scale score and inflammatory lesion counts.
In the trials, patients have been randomized (1:1) into two treatment groups to secure either sarecycline tablets or placebo once a day for 12 weeks.
Allergan chief global research and development officer David Nicholson said: "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.”
Paratek president, chief medical officer and COO Dr Evan Loh said: “Sarecycline is a narrow spectrum antibiotic, which we believe can offer meaningful clinical benefits for patients afflicted with acne."
Image: Allergan headquarters in Irvine. Photo: courtesy of Coolcaesar