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 Pity them. Women just lost a chance to lay their
hands on a Viagra - on December 2, a committee set
up by the US Food and Drug Administration (FDA)
shot down the world's first female sexual desire
enhancement drug - Intrinsa - to be manufactured
by the Cincinnati-based Procter & Gamble. Analysts
believe that it could take longer than expected
for Intrinsa to pass the test and make it to the
market. P&G had lined up about 100 million dollars
for a marketing campaign to push the product.
Intrinsa, put simply, was supposed to be what was
Viagra was to men. Intrinsa is a testosterone
patch, which would enhance sexual desire in
post-menopausal women, pre-menopausal women with
reduced testosterone levels and women who had
hysterectomies (ovaries removed). Watson Pharma
licensed out the technology to P&G to create the
drug. Testosterone has proven capability to boost
sexual desire in both men and women and this was
the first off the labs to put it into a drug form.
The FDA sub-committee, however, did not find the
drug much arousing. The committee found that the
drug is still to clear tests on the long-term
impact of the drug. For now, Intrinsa is on the
backburner. There is expected to be 15-month delay
in approval for Intrinsa; after that, it will take
longer for the drug to reach the chemist's
shelves.
But all hope is not lost yet. Pfizer, which
successfully brought out the blockbuster Viagra
(the drug alone contributed 1.3 billion dollars to
the company's revenue in 2003) had to go through a
similar grind before finally hitting he shelves
and making Viagra a household name. P&G has long
days ahead.
Medical opinion is divided on using Intrinsa -
just as in the case of Viagra. It is suggested that
Intrinsa - or any other drug of the same genre -
should no be prescribed, unless it is tested that
the woman is suffering from low testosterone
levels. Besides, it is also suggested that
estrogen
levels should be similarly maintained at optimum
levels. It has been scientifically established
that hormone deficiency is only one of the many
possible reasons for reduced sexual desire. Many
are worried that the entry of Intrinsa or a clone
into the market may increase the pressure on
doctors to prescribe such drugs for women who may
show similar symptoms due to non-hormonal reasons.
This happened in the case of Viagra, with patient
pressure building up, and is quite likely in the
case of Intrinsa too.
P&G officials say they are not disappointed they
won't be able to launch the potential blockbuster
drug next year, but stressed the company hadn't
counted on Intrinsa to help deliver future
earnings or sales goals. "Any gains from the
launch for Intrinsa were not built into this
year's (or future years') estimates," said
spokesman Tom Millikin.
Many doctors currently use a range of other
potency-enhancement treatments for women,
including various hormones, antidepressants, and
male impotence drugs like Viagra, Bayer's (BAY )
Levitra, and Cialis, made by Eli Lilly (LLY ) and
Icos (ICOS ).
P&G has completed two large trials of the patch in
women who have had both ovaries removed. It's also
studying the patch in naturally menopausal women
who are also taking estrogen. The outfit says side
effects associated with testosterone, such as
unwanted facial hair and acne, have been mild
enough that participants didn't quit the studies
because of them.
BY JM
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