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FDA APPROVES PFIZER MEDICINE VIAGRA FOR ERECTILE DYSFUNCTION
NEW YORK, March 27 /PRNewswire/ -- The U.S. Food and Drug
Administration has approved the breakthrough oral therapy Viagra
(sildenafil citrate) for the treatment of erectile dysfunction, Pfizer
Inc (NYSE: PFE) announced today.
Taken about an hour before anticipated sexual activity, Viagra is a
tablet that works naturally with sexual stimulation. Viagra is
effective in most men with erectile dysfunction (ED), the medical term
for impotence, which is associated with a broad range of physical or
psychological medical conditions.
Discovered and developed by Pfizer, Viagra is the first in a new class
of medications known as phosphodiesterase type 5 inhibitors that
improve blood flow to the penis. In clinical trials, Viagra has been
demonstrated to restore sexual function in most patients.
"Viagra is a major scientific advance because it effectively treats a
medical condition that has a devastating impact on the quality of life
of many men and their partners," said William C. Steere, Jr., chairman
and chief executive of Pfizer Inc. "As an innovative therapy for a
significant medical need, Viagra underscores Pfizer's research-based
and patient-focused mission."
Erectile dysfunction is defined as the consistent inability to achieve
and/or maintain an erection sufficient for satisfactory sexual
activity. An estimated 30 million men in the United States are
affected by ED, according to the medical literature. The prevalence of
ED increases with age.
"Because erectile dysfunction is largely misunderstood, Pfizer will
work closely with the medical community, patients and their partners to
increase understanding of this medical condition," said Henry A.
McKinnell, Ph.D., president, Pfizer Pharmaceuticals Group.
Viagra was tested in more than 4,000 men. In 21 clinical trials, which
included men with ED that was diagnosed as mild, moderate or complete,
the median age of patients was 55. They had a broad range of conditions
associated with ED including high blood pressure, high cholesterol
levels, diabetes and prostate surgery. Patients had experienced ED for
an average of five years prior to entering the clinical trials.
Viagra was shown to be effective in approximately 7 out of 10 men
overall and was effective across patients with ED attributed to
diabetes, spinal cord injury, or psychological causes, among others.
Trial results for patients and partners were assessed using
questionnaires designed with leading academic researchers.
Viagra was well tolerated by patients in the clinical trials; drop out
rates were 2.5 percent for patients taking Viagra compared to 2.3
percent of patients taking placebo. The most common side effects of
Viagra were headache, facial flushing and indigestion. Viagra should
not be used by patients taking nitrates in any form, including the
heart medicine, nitroglycerin.
"The safety and efficacy results demonstrated in our large-scale
clinical trials were outstanding," said John F. Niblack, Ph.D.,
executive vice president of Pfizer and head of Research and
Development. "But the true value of Viagra will be measured in its
impact on the lives of millions of men suffering from ED worldwide.
The number of calls and letters our researchers have received from men
with ED and their partners is unprecedented, and underscores the
importance of an effective treatment for this medical condition."
Viagra, which received priority review from the FDA, is expected to be
available by prescription by mid-April. The wholesale price of Viagra
will be $7 per tablet. Full prescribing information is available on
request.
Pfizer Inc is a research-based health care company with global
operations. In 1997, the company reported revenues of about $12.5
billion and invested more than $1.9 billion in research and development.
SOURCE Pfizer Inc
-0- 03/27/98 /NOTE TO EDITORS: Pfizer's
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/Web site: www.pfizer.com/ (PFE)
CO: Pfizer Inc ST: New York IN: MTC SU: |
