Drug updated on 10/29/2024
Dosage Form | Injection (intravenous; 100 mg); Tablet (oral; 150 mg) |
Drug Class | Tetracycline 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.
Latest News
Summary
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Nuzyra (omadacycline) Prescribing Information. | 2021 | Paratek Pharmaceuticals, Inc., Boston, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
New Antimicrobials for Gram-Positive Sustained Infections: A Comprehensive Guide for Clinicians | 2023 | Pharmaceuticals |