Omadacycline

(Nuzyra®)

Nuzyra®

Drug updated on 10/29/2024

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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  • This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
  • Clinical Efficacy in cSSTIs: Omadacycline was found to be non-inferior to linezolid in treating complicated skin and soft tissue infections (cSSTIs), with no significant differences in clinical efficacy in both the modified intent-to-treat (MITT) and clinically evaluable (CE) populations. It performed similarly to other antibiotics in treating infections caused by Staphylococcus aureus, MRSA, MSSA, and Enterococcus faecalis.
  • Effectiveness in Mycobacterium abscessus Infections: Among patients with M. abscessus infections, 83% achieved a favorable outcome, including 'cure,' 'improvement,' or 'clinical success,' highlighting omadacycline's effectiveness in this challenging subgroup.
  • Complicated Skin and Soft Tissue Infections (cSSTIs): The safety profile of omadacycline in treating cSSTIs was comparable to linezolid, with similar mortality and adverse event rates reported between the two treatments.
  • Adverse Events and Tolerability: In the treatment of acute bacterial infections, omadacycline showed a lower risk of discontinuation due to adverse events compared to other antibiotics, though nausea (30.2%) and vomiting (16.9%) were frequently reported in one clinical trial. Additionally, no reports of Clostridioides difficile infection (CDI) were observed in phase 3 studies, indicating a low risk of CDI.
  • Population Types: All studies focused on adult patients with infections, including those with prior therapy failure for Mycobacterium abscessus, where 83% achieved favorable outcomes with omadacycline. The treatment was also indicated as preferable for patients at heightened risk of Clostridioides difficile infection (CDI) due to its low incidence of CDI.