UTI Treatment Gains Qualified Infectious Disease Product Designation
Paratek Pharmaceuticals announced that its investigational antibiotic omadacycline has been granted Qualified Infectious Disease Product (QIDP) designation for the treatment of uncomplicated urinary tract infections (uUTI).
Omadacycline is a once-daily oral and intravenous antibiotic. It has previously been granted QIDP designation for the treatment of community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI) and complicated urinary tract infections (cUTI).
"We expect to begin enrolling patients as early as December in a proof-of-concept Phase 2 study of omadacycline in uUTI, and an indication in this type of infection would broaden the opportunities for oral omadacycline in community-acquired infections," said Evan Loh, MD, COO and CMO of Paratek.
The QIDP designation was granted to omadacycline under the provisions of the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The designation means the marketing application of omadacycline in uUTI will have a priority review once it is submitted.
For more information visit Paratekpharma.com.