Allergan PLC (NYSE:AGN) and Paratek Pharmaceuticals Inc (NASDAQ:PRTK) are to file later this year for approval for their new acne drug after promising results in two phase III trials.
The trials were for a daily dose of sarecycline in-patients with moderate to severe acne and both met their 12-week primary efficacy endpoints.
Sarecycline is a narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties.
Allergan intends to submit an application to the US Food & Drug Administration (FDA) in the second half of 2017.
"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, its chief global research & development officer.
Evan Loh, Paratek’s chief operating officer, added: "Sarecycline is a narrow spectrum antibiotic, which we believe can offer meaningful clinical benefits for patients afflicted with acne."
Patients were randomized (1:1) into two treatment groups to receive either sarecycline tablets (60 mg, 100 mg and 150 mg, providing a dose of 1.5 mg/kg/day) or placebo once a day for 12 weeks.