FDA gives green light to Pivmecillinam for UTI

A recent press release by the USFDA in April 2024 affirmed its approval for Pivmecillinam tablets for women with uncomplicated urinary tract infections (UTI) driven by susceptible isolates of E. coli, Staphylococcus saprophyticus and Proteus mirabilis.

About half of all women are more likely to suffer from at least one UT infection in their lifetime. Common bacterial infections of the bladder in women without any structural abnormalities in their urinary tracts are termed uncomplicated UTIs.

This approval was based on the favourable outcomes of 3 clinical trials comparing different Pivmecillinam tablet dosing regimens to placebo, different oral antibacterial drugs and ibuprofen in treating women aged 18 and older with uncomplicated UTIs. The main measure of success was a composite response rate (clinical cure {the resolution of UTI symptoms with no new symptoms} + microbiological response {a significant reduction in bacteria cultured from patients' urine}) after 8 to 14 days of the initiation of the therapy.

• Pivmecillinam tablets compared to placebo: 62% of the 137 women who received Pivmecillinam attained the composite response, compared to just 10% of the 134 women with placebo
• Pivmecillinam tablets compared to antibacterial drug: 72% of the 127 women who received Pivmecillinam attained the response, compared to 76% out of 132 women given antibacterial
• Pivmecillinam tablets compared to Ibuprofen: 66% of the 105 women who received Pivmecillinam achieved the composite response, in contrast to 22% of the 119 women given ibuprofen

Nausea and diarrhoea were the most frequently-observed adverse events associated with Pivmecillinam. Also, those with a history of severe hypersensitivity to Pivmecillinam or other beta-lactam antibacterial; carnitine deficiency and carnitine metabolism or suffering from porphyria (a rare disorder that causes nerve or skin problems) should avoid the use of this antibiotic.

The risk of hypersensitivity reactions, severe skin reactions, depletion of carnitine, C. difficile-associated diarrhoea, and intrusion with newborn screening tests for autosomal recessive inborn error are listed as several warnings and precautions of Pivmecillinam tablets.

Priority Review and Qualified Infectious Disease Product has been designated to Pivmecillinam for its approved use.