FDA passes on female Viagra patch approval

News summary:
Source: http://www.wired.com/news/medtech/0,1286,65910,00.html?tw=wn_tophead_7

Women will likely have to wait several more years for a sexual-dysfunction treatment following a Food and Drug Administration advisory board vote Thursday that the agency should not approve a sex-hormone patch.
The majority of the advisory board agreed that Procter & Gamble's Intrinsa, a testosterone-secreting patch, improved women's sex lives.
But the board had concerns about the drug's long-term safety.
While men with sexual dysfunction have six FDA-approved treatments to choose from -- including Viagra, Cialis and Levitra, as well as gels and injected drugs -- women have none.
That's unfortunate, say sex specialists like Dr. Marc Gittelman, a urologist and director of the Miami Center for Sexual Health who participated in the Intrinsa clinical trials as well as in studies for male sexual-dysfunction drugs including Viagra, Cialis and Muse.
"I think that the information presented in the medical literature seems to imply that there's good efficacy and a reasonable safety profile."
But he added that the advisory board's recommendations are less surprising when you consider that its members are working against a backdrop of heavy criticism over safety concerns involving drugs including antidepressants and Cox-2 inhibitors like Vioxx.
The advisory board raised questions as to whether women taking estrogen might be at increased risk of some diseases if they began using the testosterone patch.
Because the patch was intended for women who are surgically menopausal, meaning they have undergone hysterectomies or had their ovaries removed, it is likely patients using the patch would be taking estrogen.
Peter Tam, Vivus' vice president of strategic planning and corporate development, said where Procter & Gamble goes from here will be instructive for his company's effort.
"A lot of testosterone products are being used off-label by women in uncontrolled doses," he said.