The data from the recently completed trial showed that Sanctura XR met its primary endpoints, reduction in frequency of urination and reduction in number of urge incontinence episodes. The trial also achieved all of its key secondary endpoints, including an increase in void volume and a reduction in the severity of urgency, a defining symptom of overactive bladder (OAB).
In addition, the drug was extremely well tolerated and had a very low incidence of dry mouth, a common side effect in patients treated for overactive bladder. The results of this trial confirm the results from the first phase III trial of Sanctura XR which the company announced in June.
“Our currently marketed product, Sanctura, possesses an excellent profile including low CNS side effects, lack of metabolic drug-drug interactions, rapid onset of action, and is excreted largely unchanged into the target organ, the bladder. We believe combining these characteristics with the convenience of once-daily dosing will significantly improve the treatment of overactive bladder patients,” stated Dr Glenn Cooper, chairman, president and CEO of Indevus.