Indevus: Sanctura XR for overactive bladder meets endpoints in phase 3 trial

By Lisa Kerner

Charlotte, N.C., June 15 - In the first of Indevus Pharmaceuticals, Inc.'s two phase 3 clinical trials, Sanctura XR for overactive bladder met its primary endpoints, reducing both frequency of urination (toilet voids) and number of urge incontinent episodes.

In addition, the trial met key secondary endpoints, including an increase in volume voided and a reduction in the severity of urgency.

The 12-week trial compared the effects of Sanctura XR 60 mg in 298 patients to 303 placebo-treated patients at 55 clinical sites in the United States, according to a company news release.

Sanctura well-tolerated, with a very low (8.7%) incidence of dry mouth, a common side effect in patients treated for overactive bladder.

"With the results of this trial, Indevus and our partner, Esprit Pharma, have the opportunity to significantly improve the treatment of overactive bladder patients with Sanctura XR," president and chief executive officer Glenn L. Cooper said in the release.

"We are looking forward to announcing the results of our second trial in July and filing a New Drug Application before the end of the calendar year."

Based in Lexington, Mass., Indevus acquires, develops and commercializes products targeting urology, gynecology and men's health.

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