Iterum Therapeutics recently announced the commercial launch of its oral antibiotic, sulopenem etzadroxil and probenecid (Orlynvah), in the US. This FDA approved treatment is indicated for uncomplicated urinary tract infections (UTIs).1
“For patients who currently have limited treatment options, Orlynvah provides a long overdue oral alternative that allows for treatment in the community. This paradigm shift in the management of patients with uUTI will not only reduce emergency department visits and hospital admissions, but it will also favorably impact patients’ quality of life,” Marjorie Golden, MD, FIDSA, Site Chief, Infectious Disease, St. Raphael Campus Yale New Haven Hospital, said in a statement.1
Learn more: SURE1 and REASSURE Trials Paved Way for FDA Approval of Orlynvah
FDA Approval
The antibiotic’s approval was based from data of 2 phase 3 trials, SURE 1 (NCT03354598) and REASSURE (NCT05584657), demonstrating its effectiveness against infections caused by Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis.2
What You Need to Know
Orlynvah (sulopenem etzadroxil/probenecid) is the first and only oral penem antibiotic available in the U.S., and the first new branded product for uncomplicated UTIs in more than 25 years.
Phase 3 trials (SURE-1 and REASSURE) demonstrated strong efficacy and favorable microbiological outcomes versus ciprofloxacin and amoxicillin/clavulanate, with good tolerability and no serious safety concerns.
Orlynvah offers clinicians and patients a much-needed oral alternative for multidrug-resistant uncomplicated UTIs, potentially reducing hospital visits and improving quality of life.
For the SURE 1 trial, oral sulopenem was evaluated against ciprofloxacin in patients with uUTIs, focusing on quinolone-susceptible and nonsusceptible uropathogens. In the ciprofloxacin-nonsusceptible group, clinical success was achieved in 83% of the sulopenem group versus 62.6% in the ciprofloxacin group, while microbiological success was noted in 74.1% of patients treated with sulopenem compared with 49.6% for ciprofloxacin, both with statistically significant differences.3
In the mMITT population (all MITT patients with baseline urine cultures positive for Enterobacterales or Staphylococcus saprophyticus at ≥105 colony- forming units (CFU)/mL and ≤2 species of microorganisms), sulopenem was noninferior to ciprofloxacin with combined clinical and microbiologic response rates of 65.6% and 67.9%, respectively.
For the REASSURE study, oral sulopenem against amoxicillin/clavulanate (Augmentin) in a cohort of 2222 adult women with uUTIs. In the amoxicillin/clavulanate-susceptible group, clinical success rates were comparable, with sulopenem at 77.3% and amoxicillin/clavulanate at 76.7%. Microbiological success favored sulopenem at 75.2% compared with 66.7% for amoxicillin/clavulanate, indicating a significant advantage.4
