EMSELEX is a once-daily M3 selective receptive antagonist (M3 SRA) oral treatment that works by selectively inhibiting the M3 receptor, the primary mediator of detrusor contraction, whilst sparing the M1 and M2 receptors that are located in various body organs, including the brain and heart. EMSELEX has been shown to effectively reduce the number of weekly incontinence episodes by up to 77% versus placebo. Additional clinical trials comparing EMSELEX with placebo showed that EMSELEX does not impair cognitive function and has a cardiovascular safety profile similar to placebo.
To date, 98 clinical trials with EMSELEX have been completed 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 the number of incontinence episodes leading to a change in clothing or pads.2
EMSELEX® (darifenacin hydrobromide),7.5mg and 15mg, was granted approval by the European Commission for the treatment of overactive bladder (OAB) in all 25 European Member States as well as Norway and Iceland on 27th October 2004. Novartis is able to market EMSELEX throughout these countries. This product is known as Enablex in the US. The US Food and Drug Administration issued an approvable letter in October 2003 for the approval of Enablex in the US, and discussions with the FDA are progressing according to schedule.
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), usually with urinary frequency (voiding the bladder too often), and nocturia (waking at night one or more times to void the bladder).