Basel, Switzerland (ots/PRNewswire)
- 4.5 Million Americans Suffer from Constipation Most of the Time
Novartis Pharma AG announced that the U.S. Food and Drug
Administration (FDA) today approved a supplemental indication for its
pro-motility agent Zelnorm(R) (tegaserod maleate) for the treatment
of chronic idiopathic constipation in male and female patients less
than 65 years of age.
The new indication is supported by safety and efficacy data from
the two largest and longest randomized, double-blind,
placebo-controlled , multi-national Phase III clinical trials ever
conducted in chronic constipation. The two three-month trials
included more than 2,600 male and female patients. In addition, one
of the studies included a 13-month extension safety study of 840
patients. Zelnorm was found to significantly increase the frequency
of complete spontaneous bowel movements as well as to provide relief
of the multiple symptoms of chronic constipation that patients
complain about most, including straining, hard stool, incomplete
evacuation, infrequent defecation, bloating and abdominal discomfort.
"Chronic constipation has a tremendous impact on patients' lives,
with nearly a million visits to emergency rooms every year, almost
six million visits to doctors' offices, and thousands of
hospitalizations," said Joerg Reinhardt, Head Development, Novartis
Pharma AG. "We are very pleased the FDA has found Zelnorm safe and
effective and has approved it for treatment of patients with chronic
constipation. Novartis believes it will help bring relief to millions
Zelnorm has been available since July 2002 as the first and only
prescription medication proven to provide women with the relief of
abdominal discomfort or pain, bloating and constipation associated
with irritable bowel syndrome (IBS). IBS with constipation and
chronic idiopathic (meaning not due to other diseases or drugs)
constipation are both lower gastrointestinal dysmotility disorders.
Constipation, including that due to other diseases or drugs, is
one of the leading gastrointestinal complaints in the United States,
affecting nearly 18 percent of the population, or 37 million people.
More than 4.5 million Americans report they are constipated most of
the time. Chronic constipation, as a whole, accounts for more than
5.7 million constipation-related outpatient visits each year, with
990,994 to emergency rooms and 586,868 to hospital outpatient
facilities. It leads to more than 282,000 in-patient hospitalizations
with constipation as the primary diagnosis. Diagnosed cases of
chronic constipation are evenly distributed across age groups and in
both genders, although it is slightly more frequent in women.
A Need for New Therapies
"Chronic constipation can have a huge impact on the sufferer's
quality of life," says Larry Schiller, M.D., Attending Physician,
Baylor University Medical Center, Dallas, Texas. "In addition, many
chronic constipation patients have expressed dissatisfaction with the
efficacy and tolerability of standard treatment options including
fiber, osmotic laxatives or bulking agents. Zelnorm offers a new
proven option for these patients."
A recent survey with 557 patients found that 47 percent of
patients with chronic constipation were not completely satisfied with
currently available therapies due to the efficacy of these agents (82
percent) and the safety and side effects (16 percent). More than half
(52 percent) of respondents felt that chronic constipation adversely
impacted their quality of life.
In another survey of 311 primary care physicians, 98 percent
reported that constipation was at least somewhat bothersome to their
patients, with 95 percent describing constipation as having some
impact on patients' quality of life. Furthermore, 60 percent of these
physicians agreed that they do not have adequate products to treat
patients with constipation, and 91 percent wished that better
treatment options were available.
As a pro-motility agent, Zelnorm acts as an agonist at 5HT4
(serotonin type 4) receptors in the GI tract and mimics the natural
effects of serotonin by activating 5HT4 receptors, which normalizes
impaired motility in the GI tract, inhibits visceral sensitivity and
stimulates intestinal secretion. Zelnorm treats dysmotility symptoms
caused by chronic constipation and IBS with constipation.
Zelnorm is indicated for the short-term treatment of women with
IBS whose primary bowel symptom is constipation. The safety and
effectiveness of Zelnorm in men with IBS with constipation have not
Zelnorm is also indicated for the treatment of patients less than
65 years of age with chronic idiopathic constipation. The
effectiveness of Zelnorm in patients 65 years or older with chronic
idiopathic constipation has not been established.
Overall, safety data is now available in more than 11,600 patients
who have enrolled in clinical trials assessing Zelnorm's safety and
efficacy in various GI conditions.
In chronic constipation studies, the incidence of adverse events
with Zelnorm was similar to that of placebo. The only adverse event
reported more often with Zelnorm 6 mg twice-a-day than placebo was
diarrhea (6.6 percent vs. 3 percent). Diarrhea rarely led to
discontinuation of the study (0.9 percent). Typically, diarrhea was
transient, lasting two days, and generally resolved without rescue
medication or interruption of treatment. Data from the trial that
incorporated a 13-month extension study showed Zelnorm to be
generally safe and well tolerated long term.
In IBS with constipation clinical trials, tolerability to Zelnorm
was similar to placebo. The only adverse event reported notably more
often with Zelnorm than with placebo was diarrhea (9 percent vs. 4
percent). The majority of patients reporting diarrhea had a single
episode and in most cases, diarrhea occurred in the first week of
treatment. Typically, it resolved with continued therapy. Serious
consequences of diarrhea, including hypovolemia, hypotension and
syncope, have been reported in the clinical studies (0.04 percent)
and during marketed use of Zelnorm. In some cases, these
complications have required hospitalization for rehydration.
Zelnorm was developed by Novartis and is also known in some
countries as Zelmac. It is approved in more than 55 countries for IBS
with constipation. Zelnorm also is approved for use in chronic
constipation in 10 countries, including Mexico and Latin America.
Zelnorm is being studied as a potential treatment for other important
GI motility disorders, including gastroesophageal reflux disease
(GERD) and dyspepsia.
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
This release contains certain forward-looking statements relating
to the Company's business, which can be identified by the use of
forward-looking terminology such as "believes", "can have", "offers"
or similar expressions, or by express or implied discussions
regarding potential future sales of Zelnorm. Such forward-looking
statements reflect the current views of the Company with respect to
future events and are subject to certain risks, uncertainties and
assumptions. There can be no guarantee regarding potential future
revenues from Zelnorm. In particular, management's expectations could
be affected, among other things, uncertainties relating to unexpected
regulatory actions or delays; government regulation generally; new
clinical data; unexpected clinical trial results; the ability to
obtain or maintain patent or other proprietary intellectual property
protection; competition in general; government, industry, and general
public pricing pressures; and other risks and factors referred to in
the Company's current Form 20-F on file with the Securities and
Exchange Commission of the United States. Should one or more of these
risks or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those
described herein as anticipated, believed, estimated or expected.
Novartis is providing the information in this press release as of
this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a
result of new information, future events or otherwise.
ots Originaltext: Novartis International AG
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