Allergan scores a PhIII win with an acne drug now headed to the FDA
Allergan is teeing up a new drug application for sarecycline after investigators reported that the acne treatment scored promising data in two Phase III studies.
Highlighted in Allergan’s $AGN recent pipeline review as one of its late-stage drugs in the medical aesthetics and dermatology group, sarecycline is a narrow spectrum antibiotic designed to eliminate acne. The drug is partnered with Paratek $PRTK, which saw its shares shoot up 18% this morning.
“We are pleased with the results of the sarecycline Phase III program and Allergan’s intention to move ahead with an NDA submission for approval in the U.S. by the end of 2017,” said Paratek Chief Medical Officer Evan Loh.
Allergan’s partnership with Paratek is part of an ambitious effort to buy or partner up on a long range of experimental therapies for each of its core focus areas. The Botox maker has made a big investment in aesthetics and dermatology to build that franchise.
These Phase III studies compared the drug to a placebo in confirmatory trials. And while Allergan was sticking with top-line data only, the company touted a hit on the primary endpoints.
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 drug is also being studied for rosacea.