Novartis receives European marketing authorization for Emselex(R)


New M3 selective receptor antagonist treatment for overactive bladder

Basel, October 27, 2004 – Novartis Pharma AG announced today that Emselex® (darifenacin hydrobromide), 7.5 mg and 15 mg, has been granted Marketing Authorization by the European Commission for the treatment of overactive bladder (OAB) in all 25 European member states as well as Norway and Iceland.

"The approval of Emselex will provide many people in Europe who experience OAB symptoms a safe and effective new treatment option," said Jörg Reinhardt, Global Head of Development, Novartis Pharma AG. "Emselex has an excellent efficacy as well as central nervous system and cardiovascular safety profile, offering physicians a new choice for treating people with overactive bladder."

Emselex is a once-daily M3 selective receptive antagonist (M3 SRA) oral treatment that works by selectively inhibiting the detrusor muscle that controls bladder contraction while sparing the M1 and M2 receptors believed to be involved in central nervous system (CNS) and cardiovascular (CV) function, respectively.(1) Emselex has been shown to reduce the number of weekly incontinence episodes by up to 77%(2) versus placebo. Additional clinical trials have shown that Emselex works without impairing cognitive function(3) and without cardiovascular safety concerns(2).

To date, 97 clinical trials with Emselex have been carried out involving more than 10,500 subjects and patients, of whom 7,146 were treated with darifenacin. Across a range of pivotal endpoints, Emselex has been shown to significantly improve all other key symptoms of OAB, including the number of times patients had to visit the bathroom each day, bladder capacity, frequency of urgency, severity of urgency and number of incontinence episodes leading to a change in clothing or pads.(1)

About OAB
Symptoms of overactive bladder include urinary urgency (a sudden and compelling desire to pass urine, which is difficult to defer) with or without urge incontinence (involuntary leakage accompanied by urgency), urinary frequency (voiding the bladder too often), and nocturia (waking at night one or more times to void the bladder).

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Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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