New drug looks good for treating overactive bladder

Once-daily treatment with a drug called solifenacin improves all the major symptoms of overactive bladder, according to a UK study.

"I think it is very important to point out that we need to have more effective treatments for overactive bladder, as not one drug suits all," Dr. Linda Cardozo from King's College Hospital, London, UK told Reuters Health. "Hopefully, with good efficacy and a low side effect profile, compliance with therapy will be improved."

Solifenacin acts on muscarinic receptors in the smooth muscle of the bladder. It was developed in Japan by Yamanouchi, and was submitted for approval by regulators in the US and Europe nearly two years ago under the name Vesicare.

It was approved in Europe in August this year.

In October last year, Yamanouchi received an "approvable letter" from the US Food and Drug Administration, and the company said that after completing the request by the FDA for additional clinical data the drug could be launched this year. Vesicare will be co-promoted with GlaxoSmithKline Plc in the United States.

Cardozo and her colleagues assessed the efficacy and safety of solifenacin in a 12-week trial involving 907 patients with overactive bladder.

Compared with placebo, solifenacin treatment decreased in the average number of urination episodes, urgency episodes, and nighttime episodes, the researchers report the Journal of Urology. Results were somewhat better with the 10-milligram dose than with the 5-milligram dose.

Solifenacin also resulted in greater reductions in the average number of incontinence episodes. In addition, half the patients who were treated with either dose of solifenacin had no incontinence at the end of the study.

Adverse events were typical of this type of drug - dry mouth, constipation, and blurred vision - the researchers note, and there were no safety problems.

"The efficacy of this drug has been shown in all four major symptoms of overactive bladder - daytime frequency, (nighttime urination), urgency, and incontinence," Cardozo concluded.

"In clinical practice," she added, "I have been initiating solifenacin therapy at a dose of 5 milligrams daily for a period of 6 weeks, after which the patient is reviewed and given the option to remain on the 5- mg dose or increase to 10-mg dose."

SOURCE: Journal of Urology, November 2004.