Global pharmaceutical company Allergan and biopharmaceutical company Paratek have confirmed that two phase 3 trials of sarecycline met their 12-week primary efficacy endpoints.
1.5mg of oral sarecycline was compared with a placebo in subjects with moderate to severe acne based on the Investigators Global Assessment (IGA) scale score and inflammatory lesion counts.
Patients were randomised (1:1) into two treatment groups to receive either sarecycline tablets or a placebo once a day for 12 weeks. Sarecycline was statistically significantly (p<0.004) superior to placebo with respect to primary efficacy endpoints.
The most common adverse events (>2%) reported in the sarecycline group were nausea (3.2%) nasopharyngitis (2.8%), and headache (2.8%). The rate of discontinuation due to adverse events among sarecycline-treated patients in the two studies combined was 1.4%.
"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 and 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."