FDA Awards Paratek Fast Track for Omadacycline

Paratek Pharmaceuticals gained access to the FDA’s fast track for omadacycline for treatment of acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia and complicated urinary tract infections.

The drug is being developed as a once-daily oral and IV therapy to treat serious community-acquired bacterial infections, particularly when antibiotic resistance is of concern.

Omadacycline was previously designated as a qualified infectious disease product by the FDA for the aforementioned infections, making it eligible to benefit from certain incentives provided by the Generating Antibiotic Incentives Now Act, including FDA priority review and eligibility for fast-track status.

The drug also would be eligible for five additional years of patent exclusivity.