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
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)
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