| FDA
Approves Alternative to Viagra
August 20,
2003
The nod for Levitra ends impotence pill monopoly
and may help men for whom Viagra
never worked.
WEDNESDAY, Aug. 20 (HealthDayNews) -- Make
room, Viagra. You're not the only erection
pill on the block anymore.
The Food
and Drug Administration on Tuesday approved
Levitra, the second impotence drug to be marketed
in the United States and the first to rival
Viagra, which has singlehandedly dominated the
U.S. scene since 1998.
The drug, which has been available in Europe
since March, is expected to hit U.S. pharmacy
shelves within a few weeks. A third drug for
erectile dysfunction (ED), Cialis, has also
been approved in Europe and is expected to debut
this side of the Atlantic later this year. Still
another, Uprima, applied for approval last year
after having withdrawn because it led to fainting.
"It's exciting news, very exciting,"
says Dr. Natan Bar-Chama, director of male reproductive
medicine and surgery at Mount Sinai Medical
Center in New York City.
Some 30 million men in the United States suffer
from ED, and
it is estimated that more than half of all men
over the age of 40 are affected by the disorder
to some degree. Only about 10 percent or 15
percent of men with the problem are being treated,
however.
"Despite the media attention, there is
still a huge underlying need to have men realize
that they may have a problem and to raise their
hand and come to their doctor," says Dr.
Marc Gittelman, founder and director of the
Miami Center for Sexual
Health, who has also been involved in clinical
trials for Viagra, Levitra, and Cialis.
It's not entirely clear how Levitra, made by
Bayer AG and distributed in the United States
by GlaxoSmithKline, and Viagra, made by Pfizer,
will complement or compete with each other.
Both drugs belong to the same family of medications:
PDE5, or phosphodiesterase 5 inhibitors. These
both work by inhibiting the enzyme that degrades
the erection, Gittelman explains.
Experts anticipate that Levitra (scientifically
known as vardenafil) will be a natural for men
who have not benefited from Viagra. "Certainly
patients who have tried Viagra and have had
suboptimal response now have a new agent and
are candidates," Bar-Chama says.
"Virgin" patients will also be candidates.
"Millions of men who are untreated we are
hoping will come in," Gittelman says. "Levitra
will be used as a first-line drug. It's an equal
choice."
There have been no head-to-head comparisons
of Levitra and Viagra, but much data is suggestive,
Gittelman says. Levitra seems to work faster
than Viagra, with a "window of opportunity"
of 16 minutes to five hours vs. the average
one to four hours that are indicated on Viagra's
package insert.
There are also no food or alcohol restrictions
on Levitra, so romantic dinners are not out
of the question. The general recommendation
for Viagra is to take it after a low-fat meal
or on an empty stomach because fatty foods inhibit
absorption of the drug.
Levitra also seemed to have some advantages
in quality-of-life areas. "Men were actually
pleased with the firmness of their erection.
There was an improvement of orgasm function
[a category that includes ease of achieving
an orgasm]. They also felt that their general
overall sexual
experience was improved," Gittelman
says.
Finally, 86 percent to 92 percent of men are
expected to have improvement in erections on
Levitra. Of all the men that respond, 91 percent
are expected to have success in subsequent attempts.
This data is based on more than 50 clinical
trials involving more than 5,700 men.
The recommended dose for Levitra is 10 milligrams.
A 20-mg pill is also available for those who
don't respond, along with 2.5 mg and 5 mg for
patients who have certain medical conditions
or are taking other drugs. Levitra should not
be used more than once a day.
The medication also comes with certain warnings.
It should not be used by people taking nitrate-containing
medications or alpha-blockers, or who have a
rare heart condition known as "prolongation
of the QT interval."
It's also not recommended for those who have
had a heart attack or stroke within the last
six months, who have significantly low blood
pressure, uncontrolled high blood pressure,
unstable angina, severe liver impairment, end
stage renal failure requiring dialysis, or retinitis
pigmentosa. The most common side effects reported
were headaches, flushing, rhinitis and indigestion.
In the meantime, Pfizer has filed a lawsuit
claiming that one of its patents would be infringed
by the sale of Levitra.
More information
For more on the new drug, visit Levitra.com.
For more on sexual function issues, visit the
Consortium for Improvement in Erectile Function
or the National Institute of Diabetes and Digestive
and Kidney Diseases.
source:-http://www.healthcentral.com
|
