By IDSE News Staff
The FDA approved sulopenem etzadroxil (Orlynvah, Iterum Therapeutics) to treat uncomplicated urinary tract infections (uUTIs) caused by specific bacteria in adult women with limited or no alternative oral antibacterial treatment options.
The FDA approval of sulopenem etzadroxil was based on a clinical development program supported by a robust data package, including two pivotal, phase 3 clinical trials (known as SURE 1 and REASSURE) that evaluated the safety and efficacy of sulopenem compared with ciprofloxacin (SURE 1) and Augmentin (amoxicillin-clavulanate) (REASSURE) in the treatment of adult women with uUTIs. SURE 1 showed superiority to ciprofloxacin in fluoroquinolone-resistant infections, while REASSURE showed noninferiority and statistical superiority to Augmentin in the Augmentin-susceptible population. Sulopenem was well tolerated in both SURE 1 and REASSURE clinical trials.
“The FDA approval of sulopenem is tremendous news for those of us who have been hoping for a new option to treat appropriate at-risk patients suffering from UTIs,” said Marjorie Golden, MD, FIDSA, the site chief, Infectious Disease, St. Raphael Campus of Yale New Haven Hospital, in Connecticut. “Based on the totality of clinical data generated, sulopenem has the potential to be an important treatment alternative for use in the community.”
Sulopenem etzadroxil is a novel oral penem antibiotic that possesses potent activity against Enterobacterales spp., including those that encode extended-spectrum beta-lactamase or AmpC-type beta-lactamases that confer resistance to third-generation cephalosporins. A combination of sulopenem etzadroxil, a penem antibacterial and probenecid, a renal tubular transport inhibitor, Orlynvah is indicated for the treatment of uUTIs caused by Escherichia coli, Klebsiella pneumoniae or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.
UTIs are among the most common bacterial infections encountered in the community. Up to 60% of women will have a uUTI in their lifetime. Up to 40% of women with a history of uUTIs will have a recurrence of their infection. There are approximately 40 million uUTI prescriptions generated annually in the United States, and the company estimates approximately 1% of those infections are caused by pathogens that are resistant to all commonly available classes of oral antibiotics. Rising antibiotic resistance, an aging population with comorbidities and suboptimal safety profiles of existing oral treatment options are making antibiotic selection more challenging for treating physicians.
To reduce the development of drug-resistant bacteria, sulopenem etzadroxil should be used only to treat uUTIs that are proven or strongly suspected to be caused by susceptible bacteria. Culture and susceptibility information should be used in selecting or modifying antibacterial therapy.
The most common adverse reactions in patients treated with sulopenem etzadroxil were diarrhea, nausea, vulvovaginal mycotic infection, headache and vomiting. For the full prescribing information, click here.