Depomed, Inc. has received approval from the United States Food and Drug Administration (FDA) for Proquin XR, a once-daily, extended-release formulation of ciprofloxacin hydrochloride for the treatment of uncomplicated urinary tract infections (UTIs).
Proquin XR is the first version of ciprofloxacin with nausea and diarrhoea listed as "uncommon" adverse events in its label, rather than "common" adverse events. As a class of compounds, ciprofloxacin and other fluoroquinolones are cited in literature as causing nausea and diarrhoea and these types of side effects are reportedly the most frequent reason that patients discontinue ciprofloxacin treatment, a release from the company says.
"Urinary tract infections result in an estimated 10 million doctor visits each year, and the most frequently prescribed drug is ciprofloxacin," said Neal Shore, medical director, Carolina Urologic Research Centre. "Proquin XR is a new, once-daily version of ciprofloxacin that caused fewer incidences of gastrointestinal side effects, including nausea and diarrhoea, in the recent multi-centre Phase III clinical trial of over 1,000 patients," Shore added.
According to Depomed's own dissolution studies, CIPRO and generic equivalents release their entire dosage within approximately 30 minutes and even once-daily CIPRO XR releases its dosage within approximately two hours, while Proquin XR is designed to gradually release the drug over six hours. This extended release avoids large quantities of drug being dumped into the patient's intestinal system, where it can cause side effects or interactions with gastrointestinal drugs. In a randomized, double-blind, Phase III clinical trial of 1,037 patients with uncomplicated UTIs, Proquin XR eradicated the bacteria most commonly responsible for causing UTIs comparably to twice-daily CIPRO.