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Phase 3 Study Initiated for Trospium Chloride
The program consists of two 12-week, double-blind, placebo-controlled studies totaling 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.
"We are pleased to announce the initiation of the Phase 3 clinical program for Sanctura XR," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "Indevus continues to be on track to file a New Drug Application with the U.S. Food and Drug Administration 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."
Sanctura is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The most commonly reported side effects in Phase III U.S. clinical trials were dry mouth and constipation. Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to Sanctura should not use Sanctura.
About Overactive Bladder
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. OAB is estimated to affect between 33 million Americans, and it represents a significant clinical problem with potential medical, hygienic, and social consequences. When untreated, this condition can lead to disability, dependence, and isolation from the community. It is most prevalent among the elderly and strikes women twice as frequently as men. It is estimated that the diagnosis and treatment costs associated with OAB exceed $32 billion annually, and based on the aging population and increasing human life expectancy, these costs are expected to grow significantly.
Source: Indevus Pharmaceuticals