The FDA has granted approval to oral sulopenem sulopenem etzadroxil and probenecid; Orlynvah for the treatment of uncomplicated urinary tract infections uUTIs 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, Iterum Therapeutics announced in a news release.
According to the company, oral sulopenem is the first oral penem approved for use in the US. According to the company, oral sulopenem is the first oral penem approved for use in the United States. In SURE 1, oral sulopenem demonstrated superiority over ciprofloxacin in the treatment of patients with fluoroquinolone-resistant infections and non-inferiority to ciprofloxacin in the treatment of patients with a quinolone-susceptible uropathogen.
The approval of oral sulopenem comes after a meeting of the FDA's Antimicrobial Drugs Advisory Committee to discuss the potential benefits and risks associated with approval of the New Drug Application of the oral penem. In the discussion, the members indicated that a more specific indication may prevent off-label use, and post-market observation of changes to the rates of antimicrobial resistance may be necessary.
In SURE 1, oral sulopenem demonstrated superiority over ciprofloxacin in the treatment of patients with uUTI with a quinolone non-susceptible uropathogen. The oral penem also demonstrated non-inferiority to ciprofloxacin in the treatment of patients with uUTI with a quinolone-susceptible uropathogen. Specifically, in the quinolone non-susceptible population, the overall response rate at the test of cure visit day 12 was Microbiologic success was achieved by In the quinolone-susceptible population, the overall response rate at the test of cure visit on day 12 was Clinical success was achieved in Of those, were included in the micro-MITT population.
The quinolone-susceptible population microMITT S consisted of patients in the sulopenem arm and patients in the ciprofloxacin arm. The quinolone non-susceptible population microMITT R consisted of patients in the sulopenem arm and patients in the ciprofloxacin arm. Specifically, data from the trial showed that overall response was achieved in Further, clinical success defined as symptom resolution and no new uUTI symptoms was achieved in Regarding safety, treatment was generally well-tolerated in both study groups.
