Viagra
Alternative Seeks Approval Once Again
Drug manufacturer says
fainting problems with Uprima are solved
A drug manufacturer is
once again seeking US Food and Drug Administration (FDA)
approval for a new kind of erection pill.
Uprima, whose original
application to the FDA was pulled in 2000 after
concerns were raised that it caused fainting spells, has been further
studied in lower dosages, says its manufacturer, TAP Pharmaceuticals.
The company withdrew its original application under pressure, even
though a key FDA advisory panel recommended its
approval.
"We've completed several
new studies to evaluate the safety and efficacy of Uprima at two
and three milligrams, and we feel we have provided the FDA
with the best new drug application for Uprima," says Kim Modory,
a spokeswoman for the drug company, located in Lake Forest, Ill.
The new application was submitted in October. Uprima has already
been approved and is available in Europe.
How
Uprima Works
Uprima is a drug that
acts on dopamine, a brain chemical central to sexual arousal. It
is taken in pill form, and dissolved under the tongue, producing
an erection in 20 minutes, says Dr. John Mulhall, a urologist at
Weill Medical College of Cornell University and New York Presbyterian
Hospital in New York City. He has run several of the clinical trials
of the drug, studies that included doses as high as six milligrams
as well as the new ones with the lower doses.
Uprima behaves differently
from Viagra, Pfizer's blockbuster erection drug, which acts by increasing
the blood flow to the penis.
Concerns
Regarding Uprima
Public Citizen's
Health Research Group, a consumer advocacy organization,
raised the concerns about Uprima. The group pointed out that the
drug, which helped about 60 percent of the men who took it, can
cause a sudden drop in blood pressure, and that men who take it
could faint, which could cause injury. Also of concern was that
the studies did not include populations with health problems for
whom Uprima might be dangerous, but who might take the drug anyway
if it were available.
Modory says that those
concerns have been addressed in the new studies.
"Using doses of two and
three milligrams, we did provide additional information on syncope
[fainting], on cardiovascular safety, alcohol, and interaction with
antidepressants," Modory says.
Dr. Robert Feldman, medical
director of a research center on erectile dysfunction, has been
following the development of Uprima and is not sure how effective
a drug it will be.
"They've done very good
studies with this, and reduced the dosage, but I just don't know
where it's going to fit in," he says.
Because of the worry about
fainting, he says, he would be leery about giving it to elderly
patients, but says there are other groups for whom it would be a
good choice.
"It's supposed to be pretty
effective among those with diabetes, and I would use it for those
men who can't take Viagra," he says. "There is also a third group
of men who want a quick response." Viagra can take up to an hour
to produce an erection, Feldman says.
Uprima
Presents New Thinking in Treating Erectile Dysfunction
He adds, though, that
Uprima represents new thinking in treating erectile dysfunction.
"There is more we're going
to learn about the brain being responsible for erections, and we're
going to see more of this in the future," Feldman says, "This drug
is just the first one out."
About 5 percent of 40-year-old
men and between 15 percent and 25 percent of 65-year-old men experience
erectile dysfunction, according to the National Kidney and
Urologic Diseases Information Clearinghouse (NIDDK), and
estimates of those suffering from the malfunction range from 15
million to 30 million American men.
Treatments have included
reviewing and changing medications that men take, diet, psychotherapy,
and—most recently—the drug Viagra, which increases blood
flow to the penis and improves the response to sexual stimulation.
Always consult your physician
for more information.
In Other Men's Health
News:
Men
Go Through Menopause, Too
As many as one third of
men experience symptoms that are consistent with menopause, say
Swedish researchers.
According to reports,
a research team from Linkoping University found that symptoms such
as sweating and hot flashes were relatively common in men over the
age of 55.
The scientists believe
the same protein—called CGRP—could be responsible for
menopausal symptoms in both men and women. The protein acts
to expand the blood vessels, which can lead to both sweating and
hot flashes.
Researchers asked more
than 1,800 men over the age of 55 whether they had experienced menopausal
symptoms. From the responses collected, they found menopausal symptoms
were more common among men who also showed symptoms typically associated
with low levels of the male sex hormone testosterone. These included
reduced muscle strength, poor stamina, and low spirits.
Always consult your physician
for more information.
Online Resources
(Our Organization is not
responsible for the content of Internet sites.)
American
Urological Association, Inc.
Men's
Health Network
National
Institutes of Health (NIH)
National
Kidney and Urologic Diseases Information Clearinghouse (NIDDK)
Public
Citizen's Health Research Group
US
Food and Drug Administration (FDA)
|
January 2003
Drug
Manufacturer Says Fainting Problems With Uprima Are Solved
How
Uprima Works
Concerns
Regarding Uprima
Uprima
Presents New Thinking in Treating Erectile Dysfunction
What
Is Erectile Dysfunction (ED)?
What
Are the Risk Factors For Erectile Dysfunction?
Men
Go Through Menopause, Too
Online
Resources
What
Is Erectile Dysfunction (ED)?
Impotence, or erectile
dysfunction, is the inability to achieve an erection, and/or dissatisfaction
with the size, rigidity, and/or duration of erections. Erectile
dysfunction affects millions of men.
Although in the past it
was commonly believed to be due to psychological problems, it is
now known that 80 percent to 90 percent of impotence is caused by
physical problems, usually related to the blood supply of the penis.
Many advances have occurred in both diagnosis and treatment of erectile
dysfunction.
What
Are the Risk Factors For Erectile Dysfunction?
According to the National
Institutes of Health (NIH), erectile dysfunction is also
a symptom in many disorders and diseases.
Direct risk factors for
erectile dysfunction may include the following:
-
prostate problems
-
type 2 diabetes
-
hypogonadism in association
with a number of endocrinologic conditions
-
hypertension (high
blood pressure)
-
vascular disease and
vascular surgery
-
high levels of blood
cholesterol
-
low levels of HDL
(high-density lipoprotein)
drugs
-
neurogenic disorders
-
Peyronie's disease
(distortion or curvature of the penis)
-
priapism (inflammation
of the penis)
-
depression
-
alcohol ingestion
-
lack of sexual knowledge
-
poor sexual techniques
-
inadequate interpersonal
relationships
-
many chronic diseases,
especially renal failure and dialysis
-
smoking, which accentuates
the effects of other risk factors such as vascular disease or
hypertension
Age appears to be a strong
indirect risk factor in that it is associated with increased likelihood
of direct risk factors, some of which are listed above.
It is estimated that nearly
5 percent of men become impotent by the age of 40, and 15 percent
to 25 percent by the age of 65. Accurate risk factor identification
and characterization are essential for prevention or treatment of
erectile dysfunction.
Always consult your physician
for more information
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