NUZYRA added to CDC Plague guidelines

Paratek Pharmaceuticals, Inc. today announced that the Company’s novel, once-daily oral and intravenous antibiotic NUZYRA (omadacycline) has recently been added to the Center for Disease Control and Prevention’s (CDC) updated report, “Antimicrobial Treatment and Prophylaxis of Plague: Recommendations for Naturally Acquired Infections and Bioterrorism Response”. NUZYRA was added as an alternative agent for the treatment, pre-exposure prophylaxis, and postexposure prophylaxis of primary bubonic and pharyngeal plague infections in adults 18 years of age and over.

According to the CDC, Yersinia pestis (Y. pestis), the bacterium that causes plague, leads to naturally occurring disease in the United States and other regions worldwide, and is recognized as a potential bioterrorism weapon. A bioweapon attack with Y. pestis could potentially infect thousands, requiring rapid and informed decision making by clinicians and public health agencies.

“We believe the inclusion of NUZYRA in the updated CDC recommendations provides additional validation of the potential clinical utility of this modernized tetracycline antibiotic to help address these types of public health emergencies including protecting our civilian and military personnel as a medical countermeasure,” said Randy Brenner, Chief Development and Regulatory Officer. “The development of new antibiotics that are effective against possible biosecurity threats is vital to ensuring our national security particularly at a time when antimicrobial resistance is growing.”

The CDC conducted a series of systematic literature reviews on human treatment of plague and other relevant topics to collect a broad evidence base to assist in the development of a comprehensive set of updated recommendations. In 2016 Paratek, through a cooperative effort with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), conducted a research study of NUZYRA against pathogenic agents, including Y. pestis, that have the potential to cause infectious diseases of public health and biodefense importance. The CDC’s full recommendations can be viewed at: Antimicrobial Treatment and Prophylaxis of Plague: Recommendations for Naturally Acquired Infections and Bioterrorism Response.

Novel Antibiotic for Pandemic Preparedness and a Bioterrorism MCM
NUZYRA is a novel once-daily oral and intravenous antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA’s attributes include a broad-spectrum of bacterial coverage that has the potential to address today’s efficacy and safety gaps in the Strategic National Stockpile (SNS) antibiotic portfolio for pandemic preparedness and offer potential utility as an important Medical Countermeasure (MCM) against bioterrorism pathogens (e.g., anthrax, plague).

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