Paratek Pharmaceuticals has announced
that omadacycline (Nuzyra), a once-daily intravenous and oral antibiotic for the treatment of community-acquired bacterial pneumonia and acute skin and skin structure infections, is now commercially available in the United States.
Omadacycline was approved
by the US Food and Drug Administration (FDA) in October and is a modern tetracycline that has activity against a broad spectrum of bacteria including gram-positive, gram-negative, and drug-resistant strains.
In addition to the commercial launch of the agent, Paratek announced that the FDA has cleared 3 antimicrobial susceptibility tests (ASTs) for use. The approved ASTs include Hardy Diagnostics’ Omadacycline Susceptibility Disk, Liofilchem Omadacycline MIC Test Strip, and Thermo Scientific Sensititre MIC Plate. Standard omadacycline powder is also available for susceptibility testing.
These resources will be available in concert with the commercial launch of omadacycline.
Paratek is hopeful that these resources will “provide additional tools that will furnish deeper clarity within the decision-making matrix that physicians use when prescribing antibiotics.”
To create a surveillance program, Paratek partnered with JMI Laboratories in order to develop the KEYSTONE initiative, which provides access to current antimicrobial surveillance susceptibility data, including data for omadacycline. KEYSTONE has been designed to monitor the prevalence of antimicrobial resistance in the United States.
According to the announcement, Paratek has also submitted a marketing authorization application of omadacycline in the European Union. Additionally, Paratek is collaborating with Zai Lab for the development and commercialization of omadacycline in the greater China region.
Under a research agreement with the US Department of Defense, omadacycline is also being studied to fight bacteria that are public health threats and of high biodefense importance, including plague and anthrax.
To stay informed on the latest in infectious disease news and developments, please sign up for our weekly newsletter.