25 Apr 2024 • The U.S. FDA has given the green light to pivmecillinam tablets for the treatment of uncomplicated UTIs linked to Escherichia coli, Proteus mirabilis, & Staphylococcus saprophyticus in adult females.

• In the clinical trial comparing the drug to placebo, 62% of the 137 subjects who received it achieved the composite response compared to 10% of the 134 who received placebo.
• In the clinical trial comparing the drug to ibuprofen, 66% of the 105 subjects who received it achieved composite response compared to 22% of the 119 who received ibuprofen.

Among the frequently encountered side effects were nausea & diarrhea. The FDA also recommended vigilance for hypersensitivity reactions, severe cutaneous adverse reactions & Clostridioides difficile-associated diarrhea.

Source: FDA | Read full story