Intrinsa for Women

What is Intrinsa

Side Effects

Skin Patch

SIDE EFFECTS

Safety of Intrinsa

Testosterone Patch

LINKS

State Hyway Patrol

Pi

INTRINSA FOR WOMEN

Sex Patch?

"Intrinsa should not be viewed as a new toy for would-be sex kittens," says Davis "but every woman has the right to a decent sex life, whatever her age. If Intrinsa proves to be the right answer - enjoy." The product would be targeted at women who have had their ovaries removed and are distressed by their low level of sexual desire.

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P&G seeks FDA clearance for sex-drive drug

P&G seeks FDA clearance for sex-drive drug
Federal panel hears experts; some urge delay for Intrinsa

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By Diedtra Henderson
Associated Press

A Procter & Gamble officials told federal health advisers today that a hormone patch aimed at restoring women's lost libido has not been linked to any serious safety problems. She urged that approval not be delayed because of an unknown risk.

"It is not uncommon to have unanswered safety questions at approval," said Joan Meyer, senior director of new drug development for Cincinnati-based P&G.

If it wins Food and Drug Administration approval, the drug, Intrinsa, would be the first to treat hypoactive sexual desire disorder in women who have had their ovaries removed or damaged and are receiving estrogen therapy.

Women with the disorder have a sex drive that is so diminished that they no longer fantasize about sex or crave it, causing stress and strained relationships. The condition affects up to 3 million surgically menopausal American women.

Clinical trials showed that women using Intrinsa had modest improvements to their sex lives. Women who applied the patch to their abdomen twice weekly had one more "satisfying sexual event" per four weeks, compared with a placebo.

The panel was hearing later today from health experts urging that approval of the drug be delayed until more long-term safety data is available.

The FDA, chastised before Congress for ignoring safety concerns with drugs, has asked its Reproductive Health Drugs advisory committee to consider whether that slim benefit offsets potential risk from long-term use of the hormone testosterone. Women using the Intrinsa testosterone patch will also take estrogen.

The Women's Health Initiative, a program established by the National Institutes of Health, found that postmenopausal women taking the hormones estrogen and progestin had higher risks of heart attack, stroke and breast cancer.

"The unexpected safety findings ... indicated that short-term or uncontrolled studies may not provide adequate estimates of the risks of hormonal therapy," FDA staff told its advisory panel.

Meyer told the panel that the company will soon have more safety data adding information for nearly 200 women who've used the patch for one year. The company will also provide safety data on 100 more women who have used the patch for 18 months. Another company official, Michael Steinbuch, argued against using a randomized clinical trial after the drug is approved. The company instead wants to observe what happens with women who are taking the drug and compare their heart disease and cancer rates with a database containing the records of 10 million patients.