Novartis Pharma AG's 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.
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. Emselex has been shown to reduce the number of weekly incontinence episodes by up to 77 per cent versus placebo. Additional clinical trials have shown that Emselex works without impairing cognitive function3 and without cardiovascular safety concerns, release from Novartis said.
"The approval of Emselex will provide many people in Europe who experience OAB symptoms a safe and effective new treatment option," Jorg Reinhardt, global head of development, Novartis Pharma AG said adding, "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."
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.
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).