Indevus Pharmaceuticals, Inc. has initiated the Phase III clinical program for Sanctura XR in patients with overactive bladder. Sanctura XR is the once-daily formulation of Sanctura, which is currently being marketed in the United States.
The program consists of two 12-week, double-blind, placebo-controlled studies totalling 1,200 adults at approximately 120 sites in the United States. The objective of the trials is to evaluate the effects of once-daily dosing of trospium chloride on urinary frequency, urge incontinence, and other related symptoms associated with overactive bladder.
Glenn L. Cooper, chairman, president and chief executive officer of Indevus said, "Indevus continues to be on track to file a New Drug Application with the US FDA in the second half of 2006. As a result of the initiation of the Phase III program, we have received a $10 million milestone payment from Esprit Pharma, our co-promotion partner for Sanctura and Sanctura XR. Remaining development milestones include a $10 million payment on submission of the NDA and a $25 million payment upon approval by the FDA."
Overactive bladder (OAB) is a medical condition whose symptoms include urinary frequency, urgency, and urge incontinence, the accidental loss of urine that occurs after the strong, sudden urge to urinate.