Bayer Corporation announced that the U.S. Food and Drug Administration (FDA) has approved Cipro XR (ciprofloxacin extended-release tablets), a new formulation of ciprofloxacin, given once-a-day over three days, for the treatment of uncomplicated urinary tract infections (UTIs) due to susceptible strains of indicated organisms. Cipro XR will be marketed for use at a dosage strength of 500 mg.
Cipro XR was developed using a bilayer matrix of the active ingredient ciprofloxacin, and enables two different release mechanisms. The first is a rapid release of ciprofloxacin, which distributes to the serum and tissues within hours. This is followed by a second extended release of the active ingredient to allow sustained levels over 24 hours.
"This is good news for patients diagnosed with uncomplicated UTIs," said Dr. Thomas Hooton, Professor, Division of Allergy and Infectious Diseases, School of Medicine, University of Washington. "Once-daily dosing may enhance patient compliance, which can be an important factor in helping to achieve better outcomes as it is often easier to remember to take one pill rather than two."
Results of a prospective, randomized, double-blinded study were included in the New Drug Application (NDA) submitted to the FDA in March 2002. The study evaluated the treatment of 891 adult women with clinical signs and symptoms of acute uncomplicated UTI, including pyuria, and a positive pre-therapy urine culture. The primary endpoint of the study, which compared 500 mg Cipro XR, given once-daily over three days, to the conventional twice-daily dose (250 mg) of Cipro (ciprofloxacin HCl), was to demonstrate that treatment with Cipro XR was not inferior to treatment with Cipro.
Results showed that Cipro XR is comparable in safety and efficacy to the conventional twice-daily dose of Cipro. The treatment groups were similar with respect to demographics and infection characteristics. Of the total treatment group, 444 were treated with Cipro XR; 447 were treated with Cipro.
According to Dr. Lawrence Posner, Senior Vice President and Worldwide Head, Regulatory Affairs, Bayer Corporation, "This study showed that Cipro XR was as effective and well-tolerated as twice-daily Cipro for the treatment of uncomplicated UTIs. This approval provides patients with a new and more convenient option for appropriate and targeted treatment."
Bayer Corporation submitted a NDA to the FDA in October 2002 to market once daily Cipro XR at a different dosage strength for the treatment of complicated UTIs. Bayer will begin shipping Cipro XR 500mg to pharmacies on January 2, 2003.