FDA News

Paratek submits NDAs for omadacycline to treat CABP, ABSSSIs

Evan Loh, MD
Evan Loh

Paratek Pharmaceuticals announced today that it has submitted two new drug applications for once-daily oral and IV formulations of its broad-spectrum antibiotic omadacycline for the treatment of community-acquired bacterial pneumonia, or CABP, and acute bacterial skin and skin structure infections, or ABSSSIs.

Omadacycline is the first drug in a new class of tetracyclines known as aminomethylcyclines, according to a press release. The NDAs are based on data from three phase 3 trials — OASIS-1, OASIS-2, and OPTIC.

In the OASIS-1 trial, omadacycline met all primary and secondary endpoints and was noninferior to Zyvox (linezolid, Pfizer) in treating ABSSSIs, including MRSA. In the OASIS-2 trial, omadacycline met all primary and secondary endpoints specified by the FDA and European Medicines Agency in patients with moderate to severe ABSSSIs. Omadacycline also achieved its primary endpoints in the OPTIC trial, which compared the safety and efficacy of the drug with moxifloxacin in patients with CABP, according to the company.

Evan Loh, MD, Paratek’s president, chief operating officer and chief medical officer, said the availability of IV and oral formulations of omadacycline will be a “tremendous value” to patients, health care providers and the health care system.

“Being able to transition from a once-daily, well-tolerated IV to a once-daily oral dose has the potential to enable earlier patient discharge while facilitating higher rates of patient compliance and reducing the length of hospital stay,” he told Infectious Disease News. “Having a bioequivalent once-daily IV and oral dose will increase the probability of a definitive cure based upon the early response on the IV formulation prior to switching to the oral. It will also potentially decrease the overall cost of care by reducing length of stay as well as readmissions for recurrent infections due to noncompliance or use of another class of oral antibiotics that do not possess a bioequivalent IV and oral formulation.”

Loh also said is it possible that the oral-only regimen could be used to treat ABSSSIs in the outpatient setting, which could potentially allow patients to avoid hospitalization altogether.

“Avoiding hospitalizations is certainly more convenient for patients and it would also reduce expenses as well as the potential for complications associated with being admitted to the hospital setting,” he said.

In addition to CABP and ABSSIs, omadacycline is being developed for the treatment of complicated and uncomplicated urinary tract infections, the release said. It has previously received fast track designation by the FDA for ABSSSIs, CABP, and both uncomplicated and complicated UTIs. Omadacycline is also being investigated as a treatment for pathogenic agents such as plague and anthrax through a research agreement with the U.S. Department of Defense. – by Stephanie Viguers

Disclosure: Loh is an employee of Paratek Pharmaceuticals.

Evan Loh, MD
Evan Loh

Paratek Pharmaceuticals announced today that it has submitted two new drug applications for once-daily oral and IV formulations of its broad-spectrum antibiotic omadacycline for the treatment of community-acquired bacterial pneumonia, or CABP, and acute bacterial skin and skin structure infections, or ABSSSIs.

Omadacycline is the first drug in a new class of tetracyclines known as aminomethylcyclines, according to a press release. The NDAs are based on data from three phase 3 trials — OASIS-1, OASIS-2, and OPTIC.

In the OASIS-1 trial, omadacycline met all primary and secondary endpoints and was noninferior to Zyvox (linezolid, Pfizer) in treating ABSSSIs, including MRSA. In the OASIS-2 trial, omadacycline met all primary and secondary endpoints specified by the FDA and European Medicines Agency in patients with moderate to severe ABSSSIs. Omadacycline also achieved its primary endpoints in the OPTIC trial, which compared the safety and efficacy of the drug with moxifloxacin in patients with CABP, according to the company.

Evan Loh, MD, Paratek’s president, chief operating officer and chief medical officer, said the availability of IV and oral formulations of omadacycline will be a “tremendous value” to patients, health care providers and the health care system.

“Being able to transition from a once-daily, well-tolerated IV to a once-daily oral dose has the potential to enable earlier patient discharge while facilitating higher rates of patient compliance and reducing the length of hospital stay,” he told Infectious Disease News. “Having a bioequivalent once-daily IV and oral dose will increase the probability of a definitive cure based upon the early response on the IV formulation prior to switching to the oral. It will also potentially decrease the overall cost of care by reducing length of stay as well as readmissions for recurrent infections due to noncompliance or use of another class of oral antibiotics that do not possess a bioequivalent IV and oral formulation.”

Loh also said is it possible that the oral-only regimen could be used to treat ABSSSIs in the outpatient setting, which could potentially allow patients to avoid hospitalization altogether.

“Avoiding hospitalizations is certainly more convenient for patients and it would also reduce expenses as well as the potential for complications associated with being admitted to the hospital setting,” he said.

In addition to CABP and ABSSIs, omadacycline is being developed for the treatment of complicated and uncomplicated urinary tract infections, the release said. It has previously received fast track designation by the FDA for ABSSSIs, CABP, and both uncomplicated and complicated UTIs. Omadacycline is also being investigated as a treatment for pathogenic agents such as plague and anthrax through a research agreement with the U.S. Department of Defense. – by Stephanie Viguers

Disclosure: Loh is an employee of Paratek Pharmaceuticals.