Drug updated on 12/11/2024
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 Complicated Skin and Soft Tissue Infections (cSSTIs): Omadacycline was found to be non-inferior to linezolid in treating 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, meticillin resistant Staphylococcus aureus (MRSA), meticillin-sensitive Staphylococcus aureus (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. 4. 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 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 |