| Monday, November 29, 2004 |
| PATCH MIGHT GIVE FEMALE SEX DRIVE A BOOST |
"There's certainly a plethora of information to sugest sexual problems are common. But there are people who don't believe women have sexual dysfunction".
(JAMES A. SIMON clinical professor fo gynecology at George Washingto University School of Medicine).
FDA HAS APPROVED 3 DRUGS FOR MEN -- SOME SAY IT'S WOMEN'S TURN
A U.S. Food and Drug Administration hearing this week will have a dramatic effect on the sex lives of American women.
An FDA panel is set to review trial data for Intrinsa, a testosterone patch that can boost a woman's sex drive. If approved, Intrinsa would be the first prescription drug for treating sexual dysfunction in women. But there's a lot more riding on the decision than the future of one drug. Several other drugs to treat disease and arousal problems in women are being studied, and whether they ever come to market may hinge on how the FDA views Intrinsa.
Thursday's hearing comes at an inopportune time for marketers of female sex drugs. The FDA is under growing scrutiny about drug safety after Merck's recent withdrawal of the athritis drug VIOXX after it was linked with heart damage. Regulators and physicians remain skittish about prescription hormones after a major study showed higher heart attack risk among older women taking menopause hormones. Although women have taken testosterone in various forms since the 1930's there's very litle reliable data on long term safety.
TIME FOR EQUAL ATTENTION
Backers of sex drugs say at least 5 million women suffer from low desire problems. Given that the FDA has approved three drugs for men -- VIAGRA, CIALIS and LEVITRA-- proponents say it's time for a woman's sexual health to receive equal attention.
INTRINSA isn't a female version of VIAGRA.While VIAGRA and similar drugs increase blood flow to the genital area, making sex physically possible for men, testosterone theraphies such as INTRINSA essentially start at the top, affecting a woman's brain and her desire for sex. Although testosterone typically is viewd as a male hormone, women plays a key role in secual desire.
Patch marketers Procter & Gamble has taken a conservative approach in seeking approval for INTRINSA only for women who have undergone surgical removal of their ovaries, a procedure that reduces half of a woman's testosterone supply.
Procter & Gamble is studying the patch in naturally menopausal women who have lost interest in sex because of waning testosterone levels as they age.
The most common side effects of INTRINSA is a minor skin reaction at the site of the patch. As a result, other drug makers are developing new ways to deliver testosterone into a woman's body. BioSante is studying LIBIGEL, a gel applied to the arm, while VIVUS is studying a patented spray delivery system. None of the drugs is expected to be available before 2006.
(by Tara Parker-Pope/ Wall Street Journal/CHISUNTIMES)
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Name: infraternam meam
Home: Chicago, United States
About Me: I am now at the prime of my life
and have been married for the past 25 years.
Sickly at times, but wants to see the elixir vita,
so that I will be able to see my grandchildren from my two boys.
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