A Food and Drug Administration advisory panel surprised all sides yesterday by unanimously recommending against approving the first medication developed to treat women's sexual dysfunction, a decision that reflects a growing emphasis on safety issues in drug regulation.
In unequivocal terms, the panel told the sponsor, Procter & Gamble Co., that it had not done sufficient long-term testing to prove that its testosterone-delivering patch is safe.
The Intrinsa testosterone patch was created for women experiencing sexual dysfunction.
(Procter & Gamble Co. Via AP)
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After reviewing studies submitted by the company, the panel had earlier concluded that the hormone patch, called Intrinsa, was somewhat effective in increasing libido and sexual satisfaction in women with low testosterone as a result of surgical removal of the ovaries.
The pending decision had triggered intense interest in the aftermath of a series of controversies over FDA's handling of drug-safety issues.
While some panel members pointed to the recent withdrawal of the arthritis drug Vioxx as a reason to demand better studies on long-term safety, the reason cited most often was the Women's Health Initiative in 2002. That landmark study found that long-term use of the hormone estrogen by millions of menopausal women, in the belief that it conferred protective health effects, had actually increased their risk of heart attack and stroke.
"I don't want to expose women to the threat of a devastating heart attack or stroke for one additional satisfying sexual exposure," said panel member Steven E. Nissen, a cardiologist at the Cleveland Clinic Foundation. "I know this sets the bar high, but we have to demand more long-term testing now that we know there are risks."
Earlier, Joan Meyer, the company's senior director of new-drug development, said, "It is not uncommon to have unanswered safety questions at approval."
Several hours after the panel's 14 to 0 vote, the company released a statement saying it was "disappointed" but "pleased that they recognized the need for a treatment option for hypoactive sexual desire disorder."
The company said it plans to work closely with the FDA on practical ways to provide additional safety data. "It is our hope that working together with the FDA we can provide women with an FDA-approved treatment option in the near future," the statement said.
The panel's decision led Jonathan A. Tobert, the nonvoting industry representative on the panel, to predict that fewer drugs will now be developed and submitted for FDA approval.