Drug updated on 3/28/2024
| Dosage Form | Injection (intravenous; 100 mg) Tablet (oral; 150 mg) |
| Drug Class | Tetracycline class antibacterials |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms.
- For the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms.
Summary
- Omadacycline (Nuzyra) is indicated for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms.
- Four systematic reviews/meta-analyses were reviewed, providing a comprehensive overview of omadacycline's efficacy and safety in treating these conditions.
- The clinical cure ratio of omadacycline was found to be similar to other antibiotics used in the treatment of acute bacterial infections, as well as its microbiological eradication rate according to one study.
- In terms of specific bacteria, no statistical differences were observed between omadacycline and comparators when treating infection caused by Staphylococcus aureus including methicillin-resistant S.aureus(MRSA), methicillin-susceptible S.aureus(MSSA), or Enterococcus faecalis.
- While there was a significant difference noted between omadacycline and comparators regarding risk for any adverse events(AEs) or treatment-related AEs, it was found that discontinuation due to an AE occurred less frequently with Nuzyra than with comparator drugs.
- Despite some reports indicating higher incidence rates for nausea and vomiting when using only oral form of this drug, overall mortality rates during treatments involving Nuzyra did not differ significantly from those involving comparator drugs across all studies analyzed here.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Nuzyra (omadacycline) Prescribing Information. | 2021 | Paratek Pharmaceuticals, Inc., Boston, MA |