- First of two Pivotal Efficacy Studies support future sNDA submission for Treatment of Pulmonary Anthrax
- Oral NUZYRA Tablets Produced in the U.S. as a Result of the Company's Onshoring Initiative were Procured by BARDA
KING OF PRUSSIA, Pa., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a privately held pharmaceutical company focused on the development and commercialization of specialty therapies for specialists and community care providers that address public health threats and important unmet medical needs, today announced positive top-line results in two important animal studies supporting the Animal Rule Development program for the Treatment of Pulmonary Anthrax. Specifically, a dose range-finding therapeutic efficacy study of NUZYRA (omadacycline) in a non-human primate (NHP) model of inhalation anthrax and a pivotal therapeutic efficacy study in a rabbit model of inhalation anthrax. The NHP study data were presented previously in a poster (ESCMID Global 2025, Vienna, Austria). The pivotal rabbit study data will be presented at a conference in Spring 2026. Anthrax is an infectious disease caused by gram-positive, rod-shaped, spore-forming bacteria (Bacillus anthracis) that can lead to severe illness and death.
The top-line data from these two studies have triggered an additional procurement of NUZYRA under the company's Project BioShield (PBS) contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Oral NUZYRA tablets associated with this procurement were produced in the United States resulting from the company's U.S. onshoring activities funded through the PBS contract.
“On the heels of the positive findings we reported last year for post exposure prophylaxis (PEP), we now have confirmatory findings in both NHP and rabbit models in therapeutic efficacy studies, further validating NUZYRA's potential to effectively treat pulmonary anthrax,” said Randy Brenner, Chief Development and Regulatory Officer of Paratek. “These data represent a significant and continued advancement of our program under the contract with BARDA which is designed to support an sNDA submission to gain an indication for the treatment of pulmonary anthrax. Paratek has been at the forefront of addressing potential bioterrorism and threats to public health associated with anthrax, and we are grateful to BARDA for continuing their longstanding partnership with us.”
With the completed studies to date, only one additional NHP pivotal study is planned to support submission of an sNDA for the treatment indication under the FDA Animal Rule Program. The approval of this indication will trigger the final procurement associated with our current BARDA contract. A separate sNDA program is also ongoing for PEP.
This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50120C00001.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a pharmaceutical company providing innovative specialty therapies for specialists and community care providers, addressing public health threats and important unmet medical needs. Paratek’s portfolio of products includes NUZYRA® (omadacycline) and XHANCE® (fluticasone propionate), and the Company seeks to diversify its portfolio in pursuit of products that have the potential to improve patient lives. Paratek is privately held by B-FLEXION Life Sciences.
In December 2019, BARDA awarded Paratek a PBS contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax.
For more information, visit https://www.paratekpharma.com/ or follow us on LinkedIn and X.
About NUZYRA
NUZYRA (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. A next-generation tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical, and other drug-resistant strains.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients.
WARNINGS AND PRECAUTIONS
Mortality imbalance was observed in the CABP clinical trial, with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients >65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.
The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.
The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.
Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline class antibacterial drugs. NUZYRA is structurally similar to other tetracycline class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.
Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
NUZYRA is structurally similar to tetracycline class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, fixed drug eruption, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.
Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.
DRUG INTERACTIONS
Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA.
Absorption of tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations.
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding is not recommended during treatment with NUZYRA.
See full prescribing information here.
MEDIA CONTACT:
Adam Silverstein
adam@scientpr.com
