New Treatment for Overactive Bladder
(East Hanover, December 22, 2004) Novartis Pharmaceuticals
Corporation announced that the U.S. Food and Drug Administration (FDA) has approved
Enablex® (darifenacin) extended-release tablets
(7.5mg and 15mg) to treat overactive bladder (OAB) with symptoms of urge urinary
incontinence, urgency and frequency. Enablex, a once-daily medication,
is a unique product which works by blocking the M3 receptor which is primarily
responsible for bladder contractions. It is expected to be available to consumers
in the U.S. in early 2005.
Enablex treats OAB in several ways. It is a potent muscarinic
receptor antagonist that helps reduce incontinence episodes, increases the
amount of urine the bladder can hold, reduces the frequency of urination episodes,
and decreases the pressure or urgency associated with the urge to urinate.
"The M3 profile of Enablex is unique among all overactive
bladder medications," said David Chaikin, MD, clinical assistant professor
of urology at New York Hospital/Cornell Medical Center. "By combining sustained
efficacy with a low incidence of central nervous system and cardiovascular
side effects, Enablex will be especially useful as a new treatment option
for overactive bladder."
The FDA approval of Enablex was based on efficacy data from
four pivotal studies and safety data from studies in which more than 7,000
patients with a mean age of 58 years were treated with varying doses of Enablex.
In these studies, patients taking Enablex experienced decreased frequency of
incontinence and urination episodes, increased bladder capacity, and decreased
feelings of urgency. Enablex was shown to reduce weekly incontinence
episodes by up to 83 percent and results were seen within two weeks of beginning
treatment. Efficacy was sustained throughout the 12-week treatment period,
and long-term safety was studied for up to one year.
"Many patients with overactive bladder do not seek treatment
for this condition and many of those who do remain unsatisfied. As we
make Enablex available in the United States, we have the potential to bring
unique benefits to these patients whose needs are not currently met," stated
Paulo Costa, president and CEO, Novartis Pharmaceuticals Corporation.
OAB, a condition that affects an estimated
33 million Americans, is caused by the untimely contraction of the bladder muscle.
At least 16 percent of the population over the age of 40 suffers from the
chronic and troublesome symptoms of OAB. Although prevalence increases
with age, the problem affects people of all ages. People
with OAB often limit travel, social and even work activities to avoid potentially
embarrassing episodes that can occur with this condition.
"Millions of patients and their
families can be profoundly affected by overactive bladder. It is important
that we continue to advance technology to bring new options to people with
overactive bladder to help them manage this condition," said Nancy Muller,
executive director, National Association for Continence.
In total, Enablex has been studied in 98 clinical trials involving
more than 10,000 people. In clinical trials, the most frequently
reported adverse events associated with Enablex were dry mouth and constipation,
however patient discontinuation rates due to these events were low.
The majority of adverse events in Enablex treated subjects were mild or moderate
and mostly occurred during the first two weeks of treatment. As with
other OAB medications, Enablex is contraindicated in patients with urinary
retention, gastric retention or uncontrolled narrow-angle glaucoma and in
patients who are at risk for these conditions. Enablex is also contraindicated
in patients with known hypersensitivity to the drug or its ingredients.
For more information on overactive bladder or incontinence,
Created: 12/22/2004  - Donnica Moore, M.D.