- The Washington Times - Wednesday, December 1, 2004

An advisory panel to the Food and Drug Administration will meet today to decide whether a skin patch to heighten the sexual arousal of older women is safe and effective and should be licensed as a new drug.

A memorandum posted yesterday on the FDA’s Web site indicates federal regulatory reviewers are uncertain whether the Procter & Gamble Co.’s new testosterone patch, known as Intrinsa, produces meaningful benefits in terms of increased sex drive or if it is safe for long-term use.

FDA reviewers cite one study that shows women who wore it “had about one more satisfying sexual experience over a four-week period than women given a dummy patch.”

In a second study, the patch made even less difference, officials said.

“It is not clear that the differences are clinically meaningful,” according to the memo.

Intrinsa works by delivering testosterone, a hormone involved in the sex drive, through the skin. FDA officials say it’s important to know whether the patch provides long-term safety, given that other sex hormones, such as estrogen, have raised the risk of further medical complications like heart disease and breast cancer.

“It is unknown whether the addition of a different hormone, testosterone, might have similar and unanticipated adverse effects,” according to the memo.

“What’s more, the women who took part in the clinical trials [of the testosterone patch] were required to be on estrogen at the same time,” which raises more safety questions, New York University psychiatry professor Dr. Lenore Tiefer said yesterday in an interview.

Dr. Tiefer said she plans to express those concerns to the FDA advisory panel at today’s hearing in Gaithersburg.

“Safety is the major concern. Some people are calling this patch the female Viagra, but Viagra is out of the system in 24 to 48 hours. This is a steroid hormone like estrogen” that can linger and cause hormonal imbalances, Dr. Tiefer said.

She added: “The trials were too short, and the population studied too narrow to give the kind of information we need, especially since Procter & Gamble plans to market this to a wide proportion of the American public.”

Procter & Gamble is officially seeking approval of Intrinsa for an estimated 10 million American women rendered menopausal after having had their ovaries surgically removed. About half of a woman’s testosterone is found in the ovaries, the remainder is in the adrenal glands. At least some of these women are known to have decreased libido as a result.

The company says another 30 million women nationwide will undergo menopause naturally next year and are also at risk for the “distress” of reduced sexual appetite. If the patch is approved by the FDA, doctors would not be restricted to reserving it for women who have had hysterectomies.

The committee that will be examining Intrinsa today is the FDA’s Advisory Committee for Reproductive Health Drugs. It will be making nonbinding recommendations as to whether the patch is ready for approval or should be subject to further prelicensing safety studies.

The hearing comes as the FDA is under fire for questions about its postmarket monitoring of the popular arthritis drug Vioxx. The drug was removed from the market by its manufacturer on Sept. 30 after clinical trials showed it nearly doubled the risk of heart disease in those taking it.

There had been some speculation that the advisory committee reviewing the Intrinsa patch could call for a further period of evaluation, such as six months or a year.

“I’ll recommend that approval be delayed. I think the risks outweigh the benefits of the patch by quite a lot,” Dr. Tiefer said.

If Intrinsa is approved, it would be the first product on the market designed to address sexual dysfunction in women. Procter & Gamble said it has “strong clinical safety and efficacy data” to support its new- drug application.

The company said its research of women who underwent surgical menopause showed that at 24 weeks there was a 74 percent increase “in the frequency of total satisfying sexual activity” in women given the patch. Desire, feelings of well-being, and orgasmic intensity also increased in that group, according to the company.

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