Wednesday, May 12, 2004

ENABLEX REDUCES OVERACTIVE BLADDER SYMPTOMS, TWO STUDIES SHOW

Results from two Phase III trials indicate that Novartis AG's pharmaceutical brand Enablex (darifenacin hydrobromide) significantly reduces symptoms of overactive bladder (OAB).

One study enrolled 439 patients who had experienced OAB symptoms for more than six months.

After 12 weeks of treatment, Enablex significantly reduced the number of weekly nocturnal awakenings (22.1 percent reduction at 7.5 mg and 22.7 percent reduction at 15 mg) as compared with placebo (3.6 percent reduction). The patient groups treated with the pharma name drug rather than placebo also demonstrated a reduction in the number of weekly incontinence episodes (68.7 percent reduction at 7.5 mg and 76.5 percent reduction at 15 mg vs. 46 percent reduction in placebo).

In another analysis, the researchers pooled data from three Enablex studies that involved 1,049 patients with OAB symptoms for more than six months.

By week 12 of treatment, Enablex provided superior improvements versus placebo in all efficacy parameters, such as reducing incontinence episodes and urge frequency and increasing bladder capacity.

"Due to its M3 receptor selectivity, Enablex has the potential to provide an effective treatment option with minimal effects on the central nervous and cardiovascular systems," said Christopher Chapple, a consultant urologist at Royal Hallamshire Hospital in the United Kingdom and one of the study investigators.

These findings were presented in San Francisco at the annual meeting of the American Urological Association.

The Food and Drug Administration, which issued an approvable letter for the drug last fall, is currently reviewing pharmaceutical name Enablex as an overactive bladder treatment. Novartis expects to launch the product this year.