US questions effectiveness of `female Viagra`

Washington: Federal health regulators said
today the first pill designed to boost the female sex drive
failed to make a significant impact on libido in two studies.

Despite missing that goal, the Food and Drug
Administration said women did report slightly more sexually
satisfying experiences.

Boehringer Ingelheim has asked the Food and Drug
Administration to approve its drug flibanserin for women who
report a lack of sexual desire, a market that drugmakers have
been targeting for more than a decade since the success of
Viagra in men.

The search for so-called "female Viagra," has proved
elusive though, with many drugs abandoned after showing
lackluster results.

On Friday the FDA will ask a panel of experts to weigh in
on the safety and effectiveness of Boehringer`s drug. The
agency is not required to follow the group`s advice, though it
often does.

The FDA will also ask its experts to comment on increased
side effects like depression, fainting and dizziness seen
among women taking the pill.

The drug, which is related to the antidepressant family,
affects serotonin and several other brain chemicals, though
it`s not clear how that increases sex drive.

"We don`t know specifically what the exact mechanism of
action is but we believe it acts on brain chemicals that have
a role in human sexual response, said Dr Peter Piliero,
executive director for Boehringer`s US medical affairs.

Since the launch of Viagra in 1998, more than two dozen
experimental therapies have been studied for so-called "female
sexual dysfunction," a market which some analysts estimate at
USD 2 billion.

The FDA has a pproved an unusual handheld vacuum device
that increases blood flow to the clitoris to increase sexual
arousal. But all drug therapies have fallen short so far.

In 2004, Pfizer halted its study of Viagra in women due
to inconclusive results. Later that year an FDA panel rejected
Procter & Gamble`s testosterone patch Intrinsa, due to risks
of heart disease and cancer.

Smaller companies are currently developing creams and
nasal sprays to increase female libido.

Dr Elizabeth Kavaler, a urologist at Lenox Hill Hospital
in New York, says arousal in women is so complicated that it
may be unrealistic to expect a pill to completely address
sexual problems.

"It`s a fairly complicated area, unlike in men`s sexual
dysfunction where there`s a major mechanical concern," said
"In women there`s no mechanical concern, so if she`s not
having a successful sex life, where is the problem?"

Bureau Report