Emselex(R) is associated with fewer side effects than oxybutynin

08/26/04

Emselex(R) - an M3 selective receptor antagonist - is a promising new option, that is effective and safe, to improve overactive bladder symptoms

Basel, Switzerland, 26 August 2004 – Emselex® (darifenacin hydrobromide), a new M3 selective receptor antagonist in development for the treatment of overactive bladder (OAB), has better tolerability and equal efficacy to oxybutynin, according to data published today. Treatment with oxybutynin was associated with almost three times the rate of dry mouth (36%), compared with Emselex® (13%) or placebo. 1 Blurred vision and dizziness were only reported with oxybutynin therapy. The majority of adverse events were mild to moderate with each treatment. The data was published at the joint meeting of the International Continence Society and the International UroGynecological Association (ICS IUGA), Paris, France.

These new data show that two weeks of treatment with both Emselex® 15mg once daily and oxybutynin 5mg three times daily, significantly improved OAB symptoms of urge incontinence and urgency compared to placebo.1 The high selectivity of Emselex® for M3 receptors, along with M1 and M2 sparing characteristics, provide clinical efficacy with a reduced potential for adverse events related to the blockade of non-M3 receptors.1 Emselex's central nervous system (CNS) and cardiovascular (CV) safety are comparable to placebo.2

"This is great news for people suffering from OAB symptoms, we now have a treatment in development that works as well as existing treatments without causing as many unpleasant side effects," said Norman Zinner, Medical Director, Western Clinical Research, Inc., Los Angeles, California, USA. "We know that 80% of patients stop their OAB treatment within six months, therefore a new treatment with improved tolerability will be welcomed by both patients and physicians alike."

Regulatory applications for Enablex/Emselex® (darifenacin hydrobromide) have been submitted to the US and European authorities for the once daily oral treatment of overactive bladder in doses of 7.5mg and 15mg. On 30th July 2004 the Committee for Medicinal Products for Human Use (CHMP), adopted a positive opinion recommending that the European Commission (EC) grant a Marketing Authorisation for Emselex® in all 25 European Union (EU) countries as well as Norway and Iceland. Upon receipt of the EC approval, Novartis will be able to market Emselex® throughout these countries. On 3 October 2003, the company received an approvable letter from the US Food and Drug Administration.

About OAB
Symptoms of overactive bladder include urinary urgency (a sudden 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.)

Anti-cholinergics are the treatment of choice for OAB and act on receptors that activate the detrusor muscle to achieve bladder control. Emselex® has been proven to reduce the number of weekly incontinence episodes by up to 77%.2

About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 80,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

Source: Eurekalert & others

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