January 10, 2004
sex-drive drug is in late stages of testing
Procter & Gamble is in the advanced stages of testing a drug
to improve the sex drive in women that executives say may be a
officials say the first-of-its-kind drug, called Intrinsa, is
intended for women suffering from a loss of sexual desire as a
result of menopause or surgery.
drug is being developed as a skin patch containing testosterone,
a hormone that affects sexual desire in women. Company officials
say if the Food and Drug Administration approves the patch, the
prescription drug could be on the market sometime in 2005.
P&G has six rival companies also working on female sexual
dysfunction drugs, but no others have reached the advanced stage
of clinical trials, called Phase III testing, according to the
trade group Pharmaceutical Research and Manufacturers of America.
stakes are large, as an estimated 9 million to 12 million women
in the United States and Europe suffer from the condition, called
hypoactive sexual desire disorder.
is also testing its Viagra product on women, but for use in treating
arousal disorder, a separate malady. A spokesman said those trials
are in Phase II.
experts estimate that any drug for female sexual dysfunction that
proves effective could achieve sales of more than $1 billion a
year. Pfizer was first to market with a drug addressing men's
sexual impotence -- Viagra, now worth more than $1 billion in
sales a year -- in the late 1990s.
the first to develop a class of drug is critical in competing
and dominating the market, said David Williams, an analyst with
Swiss American Securities Inc. in New York. He said pharmaceuticals
are an attractive business because they promise healthy profit
first in class gives you an advantage -- once they're comfortable
you have an effective product, patients and doctors kind of get
married to a brand," he said.
drug's potential is tremendous because there is currently no medication
approved by the FDA for the condition, said Dr. Margery Gass,
a professor at the University of Cincinnati College of Medicine.
Gass participated in the clinical trials as an investigator.
"Viagra has led the way in making people realize this affects
an important part of people's lives," she said. "If
you've had a healthy sexual life and it's taken away, that causes
discord in relationships. It's a quality-of-life issue."
noted that Intrinsa is different from Viagra in that it addresses
the lack of desire, as opposed to problems with physical ability.
officials stress that the federal government will ultimately decide
whether they can market the new drug, but say they are encouraged
by the results and believe they will submit a strong application
to the regulatory agency.
think our clinical trial data is very promising," said spokeswoman
Mary Johnson. She declined to say exactly when Phase III trials
would be completed.
P&G's pharmaceutical president, Mark Collar, told analysts
in Cincinnati last month that Intrinsa had "blockbuster potential."
acquired the license for Intrinsa from Watson Laboratories in
1997 and has coordinated research and trials from its Healthcare
Research Center in Mason, Ohio. The company controls the patent
as well as marketing and development rights.
III is the final testing stage that occurs before the FDA reviews
a pharmaceutical for approval as a new prescription drug.
resists comparisons to a female version of Viagra, noting the
drug works differently by restoring testosterone that affects
desire rather than improving blood flow to sexual organs.
By ALEXANDER COOLIDGE
SCRIPPS HOWARD NEWS SERVICE