FDA approves once-daily Cipro XR for treatment of complicated urinary tract infections

FDA approves once-daily Cipro XR for treatment of complicated urinary tract infections

WEST HAVEN, CONN., August 28, 2003 -- Bayer Pharmaceuticals Corporation announced that the FDA has approved a once-daily formulation of Cipro XR (ciprofloxacin* extended-release tablets) for the treatment of complicated urinary tract infections (cUTIs) and acute uncomplicated pyelonephritis (AUP), or kidney infection. The new formulation can be taken once a day for 7-14 days at a dose of 1000mg.

Cipro XR is specifically formulated to be taken just once daily to kill certain bacteria causing urinary tract infections. The new formulation was developed using a bilayer matrix of the active ingredient ciprofloxacin, which enables two different release mechanisms. The first is a rapid release of ciprofloxacin, which quickly distributes to the serum and tissues. This is followed by a second extended release of the active ingredient to achieve high concentrations of ciprofloxacin in the urine for the full 24-hour dosing interval.

In December 2002, the FDA approved Cipro XR as a once-daily, three-day treatment for uncomplicated urinary tract infections at a dose of 500mg. Cipro XR 500mg was launched in January 2003.

"The once-a-day convenience of Cipro XR may contribute to compliance among patients, thereby helping to reduce the risk of UTI relapse and subsequent resistant infection," said Dr. David Talan, Professor of Medicine, David Geffen School of Medicine at UCLA. "By combining once-a-day dosing with excellent antimicrobial activity, Cipro XR may be recommended as a convenient option for the appropriate and targeted treatment of complicated UTIs."

Results of a prospective, randomized, double-blind, North American multicenter clinical trial were included in the New Drug Application (NDA) submitted to the FDA in October 2002. The study enrolled 1,042 patients and compared 1000mg once-daily Cipro XR to a twice-daily 500 mg dose of conventional Cipro (ciprofloxacin HCl). Adult male and female patients were evaluated based on the presence of cUTI and acute uncomplicated pyelonephritis. Evaluation was based on bacteriologic and clinical outcomes.

Bacteriologic eradication (evaluated 5 to 11 days post-therapy) was achieved in 89% of patients with cUTI treated with once-daily Cipro XR and 81% of patients treated with conventional twice-daily Cipro. For patients with AUP, bacteriologic eradication of E. coli was achieved in 97% treated with once-daily Cipro XR and 100% of patients treated with conventional twice-daily Cipro.

Clinical cure (evaluated 5 to 11 days post-therapy) was observed in 96% of cUTI patients treated once a day with Cipro XR 1000mg, compared with 91% of patients receiving the traditional Cipro 500mg twice daily. For patients with AUP, clinical cure was observed in 98% of patients percent treated with once-daily Cipro XR and 96% of patients treated with conventional twice-daily Cipro.

Rates of drug-related adverse events were similar in both groups. Adverse reactions determined to be at least possibly drug-related occurring in at least 1% of patients were nausea (3%), diarrhea (2%), headache (1%), dyspepsia (1%), dizziness (1%), and vaginal moniliasis (1%). Vomiting (1%) occurred in the 1000mg group.

Indications and important safety information

Cipro XR is indicated for the treatment of uncomplicated urinary tract infections (acute cystitis) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticus (a); complicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, Proteus mirabilis, or Pseudomonas aeruginosa (a), and acute uncomplicated pyelonephritis caused by Escherichia coli.

(a) Treatment of infections due to this organism in this organ system was studied in fewer than 10 patients.

Serious and fatal reactions have been reported in patients receiving concurrent administration of ciprofloxacin and theophylline. Monitor theophylline levels if concurrent administration cannot be avoided.

The safety and effectiveness of Cipro XR in children, adolescents less than 18 years of age, pregnant women and lactating women have not been established. Cipro XR is contraindicated in persons with a history of hypersensitivity to ciprofloxacin or any quinolone, and should be discontinued at the first sign of an allergic reaction.

Adverse reactions determined to be at least possibly drug-related occurring in > 1% of patients were nausea (3%), diarrhea (2%), headache (1%), dyspepsia (1%), dizziness (1%), and vaginal moniliasis (1%). Vomiting (1%) occurred in the 1000mg dose.

Cipro XR should be administered at least 2 hours before or 6 hours after antacids containing magnesium, aluminium, calcium, or other products containing metal cations. A 2-hour window between substantial calcium intake (>800 mg) and dosing with Cipro XR is recommended.

DO NOT SPLIT, CRUSH, OR CHEW THE TABLET.

* as ciprofloxacin+ and ciprofloxacin hydrochloride

Full prescribing information for CIPRO XR can be viewed at  www.ciproxr.com

Source: Bayer Pharmaceuticals Corporation  www.ciproxr.com

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