GlaxoSmithKline Plc and Bayer AG won U.S.
approval on 19th August, 2003 to sell
impotence drug Levitra, the first rival
to the popular Viagra. The announcement, from the
U.S. Food and Drug Administration, means that
Levitra, an orange pill, will give men an
alternative to Pfizer Inc.'s famous diamond-shaped
blue pill Viagra, the drug that transformed
impotence treatment after its 1998 debut as the
first oral therapy for the impotence.
Until now, the blue, diamond-shaped Viagra
pills have been the only oral prescription drug
available for an estimated 30 million American men
who suffer some degree of impotence - most of whom
don't seek medical therapy. 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.
Experts anticipate that Levitra (scientifically
known as vardenafil) will be a natural for men who
have not benefited from Viagra.
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 and produces
fewer side effects. "Levitra offers a reliable,
effective, first-line treatment for erectile
dysfunction for a broad range of patients,
including those who have a challenging-to-treat
condition," said Andrew Witty, President, Europe,
and GlaxoSmithKline. "As a result, we believe that
Levitra offers the opportunity for increased
satisfaction for many more men," he concluded.
LEVITRA launch was successfully staged in
the major markets of United Kingdom in the month
of March, 2003. Levitra (vardenafil) orange pill
works fast and is highly potent. GSK claims that
Levitra is superior to Viagra - studies showed
that most Levitra takers were able to have
satisfying sex within 16 minutes, compared with a
wait of up to an hour for Viagra users. The name
Levitra was derived from "le", the French
masculine pronoun, and "vita", Latin for
life.
Levitra works by blocking an enzyme known as
PDE-5, which affects the blood flow to the penis.
Phosphodiesterase type 5 (PDE-%) is the
predominate enzyme found in human penile erectile
tissue and is associated with erections. PDE-5
inhibitors such as Levitra typically work by
blocking this enzyme to enhance or prolong the
erectile process.
In trials involving 1,020 men with erectile
dysfunction who took the drug for one year, the
average success rate in maintaining erections
improved to 87 percent from 14 percent with the 10
mg dose and to 86 percent from 16 percent with the
20 mg dose.