Tetracycline-class antibiotic, omadacycline (Nuzyra), is FDA approved for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), and is also being studied for other potential indications.
Omadacycline (Nuzyra) was approved by the Food and Drug Administration (FDA) in October of 2018 for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Last year, the federal agency approved an expansion for the therapy, to include an oral-only dosing regimen for CABP in adults.
Manufactured by biopharmaceutical company, Paratek Pharmaceuticals, omadacycline is a novel antibiotic with both once-daily oral and intravenous formulations. The oral-only dose for CABP has an initial dose of 300 mg twice on day 1 and 300 mg once daily thereafter for a total of 7 to 14 days. Omadacycline is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.
Paratek’s CEO Evan Loh, MD, calls the therapy, “A modernized tetracycline.”
“Not only do they [tetracyclines] have a very safe and well-tolerated profile, but by restoring its broad spectrum efficacy we have been able to recapitulate many of the very unique types of pathogens that Nuzyra could potentially treat and cure,” Loh stated.
And along with the aforementioned indications, Paratek is studying Nuzyra for nontuberculous mycobacterial pulmonary disease, which is in a phase 2b study, and they are working with the Biomedical Advanced Research and Development Authority (BARDA) on treatment for pulmonary anthrax as well as prophylaxis for people exposed to it.
Contagion spoke to Loh who provided further insights about Nuzyra, their studies and developments for this therapy, and the future direction of the company.
Loh also joined us for our latest podcast and discussed antibiotic development and antimicrobial resistance.