FDA News

FDA grants antibiotic fast track designation for community-acquired infections

The FDA has granted Paratek Pharmaceuticals fast track designation for its investigational candidate omadacycline, which is currently in phase 3 development for the treatment of community-acquired pneumonia, complicated urinary tract infections and acute bacterial skin and skin structure infections, according to a press release.

Omadacycline is being developed as a once-daily oral and IV therapy, and is the first drug in a new class of tetracyclines known as aminomethylcyclines, according to the release. The agent is designed to evade two bacterial resistance pathways seen with prior generations of tetracycline derivatives. Previous trials showed omadacycline has the potential to offer broad-spectrum coverage against gram-positive, gram-negative and atypical bacteria, and may have activity against a variety of resistant bacteria, including MRSA, penicillin-resistant Streptococcus pneumoniae, vancomycin-resistant enterococcus (VRE) and other bacteria.

In the United States, more than 2 million people are infected with antibiotic-resistant bacteria and 23,000 die annually, according to the release.

“This is a significant development for Paratek as we implement our phase 3 registration program for omadacycline,” Michael Bigham, chairman and CEO of Paratek, said in the release. “There is an increasing need for effective, well-tolerated antibiotics that can be used in both inpatient and community settings. We believe that the FDA’s fast track designation for omadacycline underscores its potential as an important treatment option for patients suffering from serious community-acquired bacterial infections, particularly when resistance is of concern.”

Two phase 3 trials are assessing oral and IV formulations of omadacycline. Earlier this year, researchers began enrolling patients with acute bacterial skin and skin structure infections to examine the safety and efficacy of omadacycline compared with Zyvox (linezolid, Pfizer). The study is expected to enroll 650 patients at 100 sites and provide data in the second half of 2016. In the other study, Paratek expects to enroll 750 patients at 150 centers worldwide to assess the safety and efficacy of omadacycline in community-acquired pneumonia. The trial is slated to launch by the end of this year, with available data projected in the second half of 2017.

The FDA has granted Paratek Pharmaceuticals fast track designation for its investigational candidate omadacycline, which is currently in phase 3 development for the treatment of community-acquired pneumonia, complicated urinary tract infections and acute bacterial skin and skin structure infections, according to a press release.

Omadacycline is being developed as a once-daily oral and IV therapy, and is the first drug in a new class of tetracyclines known as aminomethylcyclines, according to the release. The agent is designed to evade two bacterial resistance pathways seen with prior generations of tetracycline derivatives. Previous trials showed omadacycline has the potential to offer broad-spectrum coverage against gram-positive, gram-negative and atypical bacteria, and may have activity against a variety of resistant bacteria, including MRSA, penicillin-resistant Streptococcus pneumoniae, vancomycin-resistant enterococcus (VRE) and other bacteria.

In the United States, more than 2 million people are infected with antibiotic-resistant bacteria and 23,000 die annually, according to the release.

“This is a significant development for Paratek as we implement our phase 3 registration program for omadacycline,” Michael Bigham, chairman and CEO of Paratek, said in the release. “There is an increasing need for effective, well-tolerated antibiotics that can be used in both inpatient and community settings. We believe that the FDA’s fast track designation for omadacycline underscores its potential as an important treatment option for patients suffering from serious community-acquired bacterial infections, particularly when resistance is of concern.”

Two phase 3 trials are assessing oral and IV formulations of omadacycline. Earlier this year, researchers began enrolling patients with acute bacterial skin and skin structure infections to examine the safety and efficacy of omadacycline compared with Zyvox (linezolid, Pfizer). The study is expected to enroll 650 patients at 100 sites and provide data in the second half of 2016. In the other study, Paratek expects to enroll 750 patients at 150 centers worldwide to assess the safety and efficacy of omadacycline in community-acquired pneumonia. The trial is slated to launch by the end of this year, with available data projected in the second half of 2017.