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news.Indevus Pharmaceuticals has initiated a phase III clinical program for Sanctura XR in patients with overactive bladder, triggering a $10 million milestone payment from Esprit Pharma.
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Sanctura XR is the once-daily formulation of Sanctura, which is currently being marketed in the US. Esprit Pharma is co-promoting the treatment with Indevus and has agreed to pay the company a further $10 million on submission of an application for the new drug and a subsequent $25 million if it is approved by the FDA.
The clinical study consists of two 12-week placebo-controlled studies involving 1,200 adults at approximately 120 sites in the US. 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.
“Indevus continues to be on track to file a new drug application with the FDA in the second half of 2006,” said Glenn Cooper, chairman, president and CEO of Indevus.
Sanctura is indicated for the treatment of overactive bladder a medical conditions whose symptoms include urinary frequency, urgency, and the accidental loss of urine that occurs after a strong, sudden urge to urinate. Overactive bladder is estimated to affect approximately 33 million Americans.