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Last week,we reported on the US Food and Drug Administration (FDA) approval of the oral antimicrobial pivmecillinam (Pivya) for treatment of women aged 18 years and older with uncomplicated urinary tract infections (UTI).
The approval
The approval is the first in 2 decades in the US for a new antibiotic to treat UTIs, which are responsible for the greatest outpatient use of antibiotics.
The FDA based the approval on data from 3 controlled clinical trials that assessed the efficacy of pivmecillinam in women aged 18 years and older, comparing different dosing regimens to placebo, to another oral antibacterial drug and to ibuprofen. The primary efficacy measure for the 3 trials was the composite response rate, which included clinical cure and microbiologic response, assessed approximately 8 to 14 days after study enrollment.
In the study that compared pivmecillinam to placebo, 62% of the 137 participants in the study drug group achieved the composite response compared to 10% of the 134 who received placebo. In the comparison of pivmecillinam to another oral antibacterial drug, 72% of the 127 subjects treated with pivmecillinam vs 76% of the 132 who received the comparator drug achieved the composite response. Findings from the trial than compared pivmecillinam to ibuprofen showed that 66% of the 105 participants who received the antibiotic achieved the composite response compared to 22% of the 119 who received ibuprofen.
The most common side effects observed with pivmecillinam included nausea and diarrhea. Contraindications to use of the drug include a history of severe hypersensitivity to pivmecillinam or other beta-lactam antibacterial drugs, primary or secondary carnitine deficiency, and porphyria. Labeling also recommends awareness for hypersensitivity and severe cutaneous reactions, carnitine depletion, and C difficile-associated diarrhea.
