One-dose treatment for UTI approved by FDA
The Food and Drug Administration has approved for marketing Monurol (fosfomycin tromethamine), an antibiotic taken in one dose for the treatment of uncomplicated urinary tract infection (UTI). It may help avoid compliance problems, which can occur when the patient stops taking an antibiotic as soon as she starts feeling better. UTIs, also known as acute cystitis, occur almost exclusively in women, afflicting an estimated 24 million women in the United States each year, says Harvey Schneier, MD, medical director for New York City-based Forest Laboratories, which manufactures and distributes Monurol. The first of a new class of antibiotics called phosphonic acid derivatives, the drug can "maintain very high urine levels for a prolonged period of time, which therefore makes it useful for a single-dose treatment of bladder infections in women," he says. Such infections are among the most common seen by primary care physicians, he adds.
Monurol is available as an orange-flavored, water-soluble powder. A single oral dose remains active in the urinary tract for more than 31¼2 days, well above the minimum time needed to destroy the most common UTI-causing bacteria, Escherichia coli, according to the company. Forest Labs will launch the drug in April, and it will be marketed directly to consumers. The cost of Monurol will be in the mid-price range for antibiotics for UTIs, though the exact cost has not been determined. The drug was well-tolerated in clinical trials, with diarrhea being the most common side effect. It has been available in Europe since 1988.
For more information about Monurol, contact Harvey Schneier, Medical Director, Forest Laboratories, 909 Third Ave., New York, NY 10022. Telephone: (212) 224-6926. Fax: (212) 750-9152.
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