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|Paratek Pharmaceuticals Broadens Clinical Profile of NUZYRA™ (Omadacycline) with New ECCMID 2019 Data Presentations|
- New microbiology data reinforce activity of NUZYRA against broad range of pathogens commonly associated with community-acquired infections
- Study supports no dose adjustments in patients based on BMI
“NUZYRA continues to show significant clinical efficacy against resistant pathogens including MRSA and resistant strains of Streptococcus pneumoniae, which is important news for clinicians who treat these severe and sometimes life-threatening community-acquired infections,” said
In a separate sub-group analysis presented today, NUZYRA showed similar efficacy and safety in obese, overweight and healthy-weight ABSSSI patients compared to linezolid, suggesting that a fixed-dosing strategy, regardless of adult body size, will not impact the safety profile and consistently high levels of efficacy of NUZYRA in patients with skin infections.
SENTRY Surveillance Program Results (Poster #1876)
In the study, bacterial isolates were initially identified by the submitting laboratories and confirmed using a matrix-assisted laser desorption, ionization-time of flight mass spectrometry. Susceptibility testing was performed according to the
Overall, NUZYRA was highly active against Staphylococcus aureus, including methicillin-susceptible S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA) that included isolates from both ABSSSI and RTI (MIC50/90 0.12/0.25 mg/L), as well as strains displaying resistance to tetracyclines, levofloxacin, erythromycin, clindamycin and/or oxacillin.
NUZYRA was also highly active against other respiratory pathogens including Streptococcus pneumoniae including penicillin- and tetracycline-resistant strains (MIC50/90 0.06/0.12 mg/L). In addition, NUZYRA showed activity against Haemophilus influenzae, Haemophilus parainfluenzae and Moraxella catarrhalis strains (MIC50/90 0.5/1 mg/L, MIC50/90 1/4 mg/L and ≤0.12/0.25 mg/L, respectively).
UTI pathogens Escherichia coli (E. coli) and ESBL-phenotype E. coli were also shown to be susceptible to NUZYRA (MIC50/90 1/2 mg/L, and 1/4 mg/L respectively).
Safety and Efficacy of NUZYRA by Body Mass Index (ePoster #O0306)
Clinical success at early clinical response (ECR) in the modified intent-to-treat (mITT) population for NUZYRA and linezolid were similar in healthy-weight (OMC: 87.5%; LZD: 86.7%), overweight (OMC: 84.3%; LZD: 83.0%) and obese (OMC: 86.2%; LZD: 82.6%) patients. Similar clinical success was seen at post treatment evaluation (PTE) in the mITT population: healthy-weight (OMC: 82.7%; LZD: 81.8%), overweight (OMC: 84.3%; LZD: 82.2%) and obese (OMC: 88.2%; LZD: 83.2%).
The study showed no evidence of lower efficacy with increasing BMI. The observed treatment emergent adverse events (TEAEs) were consistent with the adverse event profile for the tetracycline class and there was no difference in rates of TEAEs and serious TEAEs across BMI categories or between treatment groups.
“We believe that the results of this sub-group analysis provide physicians with confidence that a fixed dosing strategy will not impact the safety and efficacy of NUZYRA in patients with skin infections and a high body mass index,” Dr. Loh said.
Paratek has submitted a marketing authorization application of omadacycline in the European Union. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.
SEYSARA™ (sarecycline) is an FDA-approved product with respect to which we have exclusively licensed certain rights in the United States to Almirall, LLC, or Almirall. SEYSARA is currently being marketed by Almirall in the U.S. as a new once-daily oral therapy for the treatment of moderate to severe acne vulgaris. Paratek retains development and commercialization rights with respect to sarecycline in the rest of the world.
Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
Indications and Usage
Community-Acquired Bacterial Pneumonia (CABP) caused by the following:
Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following:
Important Safety Information
Warnings and Precautions
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 or third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause irreversible 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.
Clostridium 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 of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, 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.
Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.
Use in Specific Populations
To report SUSPECTED ADVERSE REACTIONS, contact
Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.
Forward Looking Statements
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