FDA Accepts New Drug Application for Sanctura XR Submitted by Indevus
LEXINGTON, Mass., December 13, 2006 -- Indevus Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Companyâ€™s New Drug Application (NDA) for Sanctura XR (trospium choloride), the once-daily formulation of Sanctura, for the treatment of overactive bladder (OAB). The FDA Prescription Drug User Fee Act (PDUFA) target action date for Sanctura XR is August 13, 2007. The NDA was submitted to the FDA by the Company on October 12, 2006.
The NDA includes the results of the Companyâ€™s Phase III clinical program as well as the results of additional Phase I and Phase II studies. The previous NDA for Sanctura is also referenced for supportive data.
In addition to this clinical database, over 700,000 prescriptions for Sanctura have been written since the launch of the product in August 2004. Indevus co-promotes Sanctura with its partner, Esprit Pharma, which will also market Sanctura XR upon approval in the United States. Indevus licensed trospium chloride from Madaus GmbH, which markets the product for overactive bladder in multiple countries outside the United States.
About Sanctura and Sanctura XR
Sanctura and Sanctura XR belong to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax detrusor smooth muscle tissue found in the bladder, thus decreasing bladder contractions. Overactive or unstable detrusor muscle function is believed to be the cause of overactive bladder.
Sanctura and Sanctura XR possess a quaternary ammonium structure that may be instrumental in the low incidence of CNS side-effects. At therapeutic concentrations in vitro, Sanctura does not interact with drugs metabolized by the Cytochrome P-450 system, a metabolic pathway commonly associated with drug-drug interactions, and the majority of the absorbed dose is excreted largely unchanged into the urine.
Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to Sanctura should not use Sanctura.
Source: Indevus Pharmaceuticals, Inc.
Posted: December 2006