Darifenacin increases 'warning time' for OAB sufferers

October 13, 2003

Florence, Italy, 10th October 2003 -- Darifenacin, a new oral treatment for overactive bladder (OAB), has the potential to prolong "warning time" - the period between the first sensation of urgency and micturition - in patients experiencing OAB syndrome. This is according to data presented at the International Continence Society's 33rd Annual Congress in Florence, Italy1. Darifenacin is a new treatment option and the first M3 selective receptor antagonist (M3 SRA) currently awaiting regulatory approval in the US and Europe.

As presented by Linda Cardozo, Professor in Urogynaecology at Kings College Hospital London, urgency was reported as being one of the most distressing symptoms for patients with overactive bladder syndrome. It was suggested that, as a result, people who suffer symptoms of an overactive bladder often have a very limited social and personal life with increased psychological problems. Any help in prolonging the warning time between urgency and the embarrassment of incontinence helps the sufferer to lead a more normal life.

The multicentre, randomised, double-blind, placebo controlled study, evaluated the change in warning time of 72 patients either receiving darifenacin 30mg daily or placebo. After two weeks of treatment, patients using darifenacin showed a significant improvement in median warning time of 4.3 minutes compared with patients in the placebo group. This change represented a 22.5% increase in mean warning time for patients taking darifenacin1.

Overactive bladder is a very common condition, estimated to affect 16.5% of the worldwide adult population. Symptoms of OAB affect both sexes and increase with age - as many as 30 to 50 % of women over the age of 50 are estimated to suffer from the symptoms. In many patients, a specific cause cannot be identified. Many do not seek medical help (50-75%) and of those, who have sought medical help, 80% do not receive treatment.
-end-
This release contains certain forward-looking statements relating to Novartis Pharma AG's business, which can be identified by the use of forward-looking terminology, such as "new", "first" and "may" or similar expressions, or by discussions of strategy, plans or intentions. Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. Commercialisation can be affected by, amongst other things, uncertainties relating to regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Company's Form 20F filed with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of USD 20.9 billion and a net income of USD 4.7 billion. The Group invested approximately USD 2.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78 200 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

Refs:
1. "Can Medication Prolong Warning Time?" Cardozo L, Prescott K, Serdarevic D, Skillern L, poster presented at the International Continence Society, 33rd Annual Meeting, Florence, Italy, 5-9th October 2003

Notes to editors

Regulatory applications for Enablex/Emselex (darifenacin hydrobromide) have been submitted to the US and European authorities for the once daily treatment of overactive bladder in doses of 7.5mg and 15mg. On 3 October 2003, the company received an approvable letter from the US Food and Drug administration. Novartis expects to launch Enablex/Emselex globally in 2004.

Ketchum UK

Related Placebo Articles from Brightsurf:

Effect of fluvoxamine vs placebo on clinical deterioration in outpatients with symptomatic COVID-19
This randomized trial compares the effects of fluvoxamine, a selective serotonin reuptake inhibitor with immunomodulatory effects, versus placebo on a composite of dyspnea or pneumonia and oxygen desaturation among adult outpatients with polymerase chain reaction-confirmed mild COVID-19 illness.

Hydroxychloroquine no more effective than placebo in preventing COVID-19
Clinical trial with COVID-19 testing of participants shows health care workers in contact with coronavirus patients who took hydroxychloroquine each day did not reduce their rate of infection.

Compared to placebo, vitamin D has no benefit for severe asthma attacks
Contrary to earlier observational results, vitamin D supplements do not prevent severe asthma attacks in at-risk children, according to the first placebo-controlled clinical trial to test this relationship.

UMN trial shows hydroxychloroquine has no benefit over placebo in preventing COVID-19
Today, University of Minnesota Medical School researchers published the results from the first randomized clinical trial testing hydroxychloroquine for the post-exposure prevention of COVID-19.

The placebo effect and psychedelic drugs: tripping on nothing?
A new study from McGill suggests that, in the right context, some people may experience psychedelic-like effects from placebos alone.

Methotrexate reduces joint damage progression over placebo in erosive hand OA
According to new research findings presented at the 2019 ACR/ARP Annual Meeting, methotrexate did not demonstrate superior efficacy over placebo for pain relief and function evolution at three and 12 months in patients with erosive hand osteoarthritis, but did significantly reduce the progression of joint damage over placebo and seems to facilitate bone remodeling in these patients.

Botulinum toxin reduces chronic migraine attacks, compared to placebo
A growing body of evidence supports the effectiveness of botulinum toxin injections in reducing the frequency of chronic migraine headaches, concludes an updated review and analysis in the January issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS).

Opioids vs. placebo, nonopioid alternatives for chronic noncancer pain
An estimated 50 million adults in the United States were living with chronic noncancer pain in 2016 and many of them were prescribed opioid medications, even though a clinical benefit is uncertain.

Probiotic no better than placebo for acute gastroenteritis in children
While probiotics are often used to treat acute gastroenteritis (also known as infectious diarrhea) in children, the latest evidence shows no significant differences in outcomes, compared to a placebo.

Most common shoulder operation is no more beneficial than placebo surgery
In a landmark study published this week in the BMJ, Finnish researchers show that one of the most common surgical procedures in the Western world is probably unnecessary.

Read More: Placebo News and Placebo Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.