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Endo International plc
Drug Names(s): trospium chloride
Description: BioMedTracker has separate drug profiles for the regular release and extended release (XR) formulations of Sanctura. Please also see Sanctura XR.
Trospium belongs to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax 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.
Trospium possesses a quarternary ammonium structure and thus does not appear to have the potential to cross the blood-brain barrier. At therapeutic concentrations in vitro, trospium does not interact with drugs metabolized by the Cytochrome P-450 system, a metabolic pathway commonly associated with drug-drug interactions, and it is excreted largely unchanged in the urine.
Trospium has been extensively studied and is currently marketed as a prescription drug product in Europe, where it is one of the leading products for overactive bladder/urinary incontinence.
ndevus & Madaus
Indevus Pharmaceuticals licensed exclusive U.S. rights to trospium from Madaus AG, a German pharmaceutical company, in late 1999. In exchange, Indevus agreed to pay Madaus regulatory milestone, royalty and sales milestone payments. Indevus took over responsibility for all clinical development and regulatory activities and costs related to the compound in the U.S.
In August 2007, Rottapharm completed its acquisition of Madaus Pharma, the pharmaceutical division of Madaus Holding.
Indevus & PLIVA
In April 2004, Indevus Pharmaceuticals entered into a co-promotion and licensing agreement with PLIVA d.d. through its specialty branded subsidiary, Odyssey Pharmaceuticals, for the U.S. commercialization of SANCTURA. The agreement provided for payments to Indevus from PLIVA that included $30 million upon signing and $120 million upon the approval of SANCTURA by the FDA. In addition, Indevus received up to $45 million in future payments...See full deal structure in Biomedtracker
Partners: Allergan plc Mylan Inc.
Pink Sheet Sanctura FDA Reviewers
Pink Sheet Sanctura Clinical Development
Pink Sheet Sanctura XR to begin Phase III
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