Treatment of uncomplicated urinary tract infections
U. S. registration for Bayer's CiproŽ XR antibiotic
Once-a-day dosing simplifies administration
Leverkusen - The U.S. Food and Drug Administration (FDA) has approved Bayer's antibiotic product CiproŽ XR (Ciprofloxacin Extended-Release Tablets). This new formulation, given once a day over three days, is designed to treat uncomplicated urinary tract infections (UTIs). CiproŽ XR will be marketed in a dosage strength of 500 mg, and Bayer will begin shipping the product to U.S. pharmacies on January 2, 2003.
CiproŽ XR releases the active ingredient from two layers. The first releases ciprofloxacin into the blood within hours. This is followed by a second extended release of the active ingredient to allow sustained levels over 24 hours.
A study with 891 women showed that once-daily administration of CiproŽ XR was as effective as conventional ciprofloxacin administered twice a day. A clinical cure was achieved in 95 percent (CiproŽ XR once daily) versus 93 percent (ciprofloxacin twice daily).
Dr. Wolfgang Plischke, President of the Pharmaceuticals Division at Bayer HealthCare, commented on the registration: "We can now offer patients a more convenient medication for the targeted therapy of uncomplicated urinary tract infections."
According to the National Institutes of Health in the USA, urinary tract infections are the second most common type of infection, accounting for more than eight million doctor visits annually in the USA. Women are especially prone to UTIs.
Bayer submitted an application to the FDA in October 2002 to market CiproŽ XR tablets in a 1000 mg dosage strength for once-a-day therapy of complicated urinary tract infections.
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Dr. Michael Diehl
telephone: +49 214 30-58532