fyi, FDA approval of Tolterodine 3/26/98. typical pharma press release ... these guys are marketers through and through ... but does have some clinical data.
Peter
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Detrolr (Tolterodine Tartrate) Approved for Bladder Controlÿÿÿ
Press Release: London, March 26, 1998 -- An effective and well-tolerated
new medication for the treatment of overactive bladder has been approved
by the U.S. Food and Drug Administration. Detrol Tablets (tolterodine
tartrate tablets) offers new hope to many of the estimated 17 million
people in the U.S. coping with overactive bladder, a medical condition
which can have profoundly negative effects on their quality of life.
Detrol, a product of Pharmacia & Upjohn (NYSE: PNU) research, is the
first new medication approved for a bladder control problem in the U.S.
in more than 20 years.
Overactive bladder, marked by symptoms of urinary frequency, urgency or
urge incontinence, has only recently been recognized as a widespread
condition. Urgency is the sudden, overwhelming urge to urinate;
frequency means urinating more than eight times per 24 hours; and, urge
incontinence is the sudden and total involuntary loss of urine.
Overactive bladder and its symptoms affect adults of all ages, primarily
women, and can disrupt sleep, work, sexual activity, relationships and
social interaction. Yet, many people fail to seek medical help because
they mistakenly believe that bladder control problems are an inevitable
part of aging, or they are too embarrassed to talk about their problem
with a physician.
"People with overactive bladder now have a medication that is both
effective and well tolerated in treating their symptoms," said Rodney
Appell, M.D., head of the Section of Voiding Dysfunction and Female
Urology, Cleveland Clinic Foundation. "Detrol may provide a new sense of
freedom for many people relying upon elaborate coping mechanisms to hide
their condition."
Despite its prevalence, only an estimated 20 percent of people in the
U.S. with overactive bladder are under a physician's care.
"The availability of a new drug that is effective in the treatment of
overactive bladder and is well tolerated could have a great positive
impact on the way we manage those patients," said Alan J. Wein, M.D.,
chief of the Division of Urology at the University of Pennsylvania,
Philadelphia. "The availability of a new medication such as Detrol may
represent an additional reason to seek help for their condition for
people who would not otherwise do so."
Though many people with overactive bladder have not experienced
incontinence, they struggle with symptoms of urgency or frequency and
live with an intensifying fear that an accident may occur. As a result
of having had an overwhelming and unexpected urge to urinate, people
begin to go to the bathroom defensively, before they leave the office or
house or go anywhere, in the hope of preventing an accident. This fear
can lead people to change behaviors and adopt preventive coping
mechanisms such as limiting daily travel only to places and routes where
they know the locations of all restrooms (a practice known as toilet
mapping), reducing fluids, avoiding sexual intimacy and wearing adult
diapers or pads. Many people with overactive bladder are awakened
several times each night to urinate. Overactive bladder can result in
emotional distress and, in some cases, may contribute to depression.
In the largest clinical development program for a bladder control
medication (almost 2,000 adult patients with symptoms of overactive
bladder), Detrol (2 mg twice daily) effectively reduced the median
number of times people urinated over a 24-hour period. In three
placebo-controlled, 12-week studies with Detrol (2 mg twice daily),
patients had a significant reduction (15 to 21 percent) in median number
of urinations per 24 hours compared to baseline (baseline median ranged
from 10.4 to 11.0 urinations per 24 hours). This reduction was
significantly greater than the change for placebo-treated patients.
Data from three placebo-controlled studies showed that patients taking
Detrol (2 mg twice daily) decreased their incontinence episodes by 50 to
56 percent from baseline. This reduction was not statistically
significant compared with placebo.
The overall number of adverse events with Detrol was comparable to
placebo. Reported side effects of Detrol considered treatment-related
included dry mouth (39.5 percent for Detrol vs. 15.9 percent for
placebo), headache (11.0 percent vs. 7.4 percent), constipation (6.5
percent vs. 4.5 percent), indigestion (5.9 percent vs. 1.7 percent), and
dry eyes (3.8 percent vs. 1.7 percent).
Discontinuation from the studies due to side effects was also comparable
to placebo (8.0 percent with Detrol vs. 5.7 percent with placebo).
Detrol should not be used in patients with urinary retention, gastric
retention and uncontrolled narrow-angle glaucoma.
"Our hope is that with the approval of Detrol, patients will hear and
learn more about their condition and talk more openly with their doctor
about a new, effective treatment that may help them," said Lars
Birgerson, M.D., Ph.D., Vice President, Corporate Licensing, Pharmacia &
Upjohn.
Shipments of Detrol to wholesalers will begin in a few days. The
prescription-only medication will be available in some pharmacies in
April and will be widely available across the U.S. by early May. The
product was launched as Detrusitol in Sweden in October 1997, in the UK
in February 1998 and in Germany and Finland in March. Detrusitol has
received marketing authorization in 10 other European Union countries.
Pharmacia & Upjohn is a global, innovation-driven pharmaceutical and
health care company. Pharmacia & Upjohn1s products, services and
employees demonstrate its commitment to improve wellness and quality of
life for people around the world.
SOURCE Pharmacia & Upjohn |
