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Omadacycline

(Nuzyra®)

Nuzyra®

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 100 mg) Tablet (oral; 150 mg)
Drug ClassTetracycline class antibacterials
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms.
  • Indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms.

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Summary
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  • Nuzyra (omadacycline) is indicated for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms and for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms.
  • This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
  • Omadacycline demonstrated similar clinical and microbiological response rates to comparators in treating acute bacterial infections, with an odds ratio (OR) of 1.18 (95% CI: 0.96-1.46) for clinical cure and OR of 1.02 (95% CI: 0.81-1.29) for microbiological eradication.
  • For specific pathogens, omadacycline's effectiveness was comparable to that of other antibiotics, showing no significant differences in clinical outcomes for Staphylococcus aureus (OR = 1.14, 95% CI: 0.80-1.63) and Enterococcus faecalis (OR = 2.47, 95% CI: 0.36-16.97).
  • Omadacycline showed high clinical success in Mycobacterium abscessus infections, with 83% of patients achieving favorable outcomes, and it had the highest beneficial effect on clinical and microbiological success in skin and soft tissue infections (SSTIs) among 20 evaluated treatments.
  • Omadacycline had a lower risk of discontinuation due to adverse events in acute bacterial infections compared to comparators.
  • One patient (6%) discontinued omadacycline due to gastrointestinal intolerance in Mycobacterium abscessus infections.
  • Omadacycline had a moderately safe profile in skin and soft tissue infections, with unspecified adverse events noted.
  • No significant difference in the risk of treatment-emergent adverse events, serious adverse events, discontinuation due to TEAEs, and all-cause mortality between novel tetracyclines and other antibiotics.
  • Sitafloxacin and comparators had similar risks of treatment-emergent adverse events, drug-related TEAEs, and all-cause mortality (TEAE, OR = 1.14, 95% CI = 0.64-2.01).
  • No population types or subgroups information was available in the reviewed studies.