Drug updated on 11/8/2024
| Dosage Form | Tablet: (oral; sulopenem etzadroxil/probenecid: 500 mg/ 500 mg) |
| Drug Class | Penem antibacterials and renal tubular transport inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.
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Summary
- This summary is based on the review of one randomized controlled trial(s). [1]
- Sulopenem was noninferior to ciprofloxacin for overall success (clinical and microbiologic response at day 12) in the combined population (65.6% vs 67.9%; difference, -2.3%; 95% CI (confidence interval), -7.9 to 3.3).
- In patients with ciprofloxacin-nonsusceptible baseline pathogens, sulopenem demonstrated superior effectiveness over ciprofloxacin (62.6% vs 36.0%; difference, 26.6%; 95% CI, 15.1 to 37.4; P <.001).
- Sulopenem was not noninferior to ciprofloxacin in patients with ciprofloxacin-susceptible pathogens, with lower effectiveness largely due to increased asymptomatic bacteriuria post-treatment (66.8% vs 78.6%; difference, -11.8%; 95% CI, -18.0 to 5.6).
- Diarrhea was more frequently reported in the sulopenem group (12.4% vs 2.5%).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Orlynvah (sulopenem etzadroxil and probenecid) Prescribing Information. | 2024 | Iterum Therapeutics U.S. Limited, Chicago, IL |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Sulopenem or Ciprofloxacin for the treatment of uncomplicated urinary tract infections in women: A phase 3, randomized trial. | 1,671Subjects F: 100% M: 0% | 2023 | Clinical Infectious Diseases |
Document Title
Sex Distribution:
F:100%
M:0%
1671Subjects
Year:
2023
Source:Clinical Infectious Diseases