Indevus completes enrollment in phase 3 trial of pagoclone, first phase 2 trial of Sanctura XR

By Lisa Kerner

Erie, Pa., March 6 - Indevus Pharmaceuticals, Inc. said it has completed enrollment in its phase 2 trial for pagoclone for stuttering, and the first of its two ongoing phase 3 trials for Sanctura XR, the once-daily formulation of Sanctura for overactive bladder.

"I am very pleased to report the completion of enrollment in both of these trials," chairman, president and chief executive officer Glenn L. Cooper said in a company news release.

"Completing enrollment puts us on track to report data on the pagoclone trial by the middle of June of this year and report data on the first Sanctura XR trial by the end of June."

The phase 2 trial is an eight-week, double-blind, placebo-controlled study of 130 adults evaluating pagoclone versus a placebo in lessening the effects of stuttering.

The first of two phase 3 Sanctura XR trials is fully enrolled with about 600 patients, while enrollment of the second trial is expected to be complete within 60 days.

Both phase 3 trials are 12-week, double-blind, placebo-controlled studies evaluating the effect of Sanctura XR in reducing frequency, urgency and incontinence episodes in patients with overactive bladder.

Indevus expects to file a New Drug Application for Sanctura XR with the Food and Drug Administration by the end of the year.

Indevus is a biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting certain medical specialty areas, including urology, gynecology and men's health. The company is based in Lexington, Mass.

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