Dublin, Ireland-based drugmaker Allergan and US partner Paratek Pharmaceuticals have reported that two Phase III trials assessing sarecycline for the treatment of moderate to severe acne have hit their primary endpoints.
In the studies, sarecycline was statistically significantly superior to placebo in treating inflammatory acne lesions.
Safety-wise, the most common adverse events (>2 percent) reported in the sarecycline group were nausea (3.2 percent), nasopharyngitis (2.8 percent), and headache (2.8 percent), the firm noted.
The drug 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 positive efficacy results observed in the pivotal phase III 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."
Based on the trial data, Allergan is planning to file a New Drug Application (NDA) in the US in the second half of this year.