New Acne Treatment from Paratek Receives FDA Approval

Boston-based Paratek Pharmaceuticals has received Food and Drug Administration approval for SEYSARA (sarecycline), an orally administered, narrow spectrum tetracycline-derived antibiotic used to treat moderate to severe acne vulgaris.

The FDA approval comes after two phase-3 trials where participants took either 1.5 mg/kg of sarecycline a day or a placebo for 12 weeks. The trials determined that sarecycline improved facial lesions, and “were significantly more likely to reach the primary endpoint of improved acne,” according to Dermatology News. Few side effects were reported during the trial; 3.2 percent complained of nausea and 2.8 percent suffered from nasopharyngitis and headache. There was a 1.4 percent discontinuation rate in both studies due to these side effects.

Paratek received a $12 million milestone payment after being granted FDA approval, and they’re now eligible for tiered royalties on net sales of SEYSARA, which will be marketed in the United States by Almirall SA. The company uses novel tetracycline chemistry to develop innovative therapies. Their lead medication candidate is omadacycline, a broad-spectrum intravenous and oral antibiotic that treats “serious community-acquired bacterial infections, including community-acquired bacterial pneumonia, acute bacterial skin and skin structure infections, and urinary tract infections,” according to a press release.