Enablex,
a once-daily medication, is expected to launch in the U.S. in early 2005.
Enablex works
by blocking the M3 receptor, which is primarily responsible for bladder
muscle contraction. 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 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.
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.
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.
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Copyright 2005 by United
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