- Viagra
- Sildenafil Citrate (TP)
- Sildenafil Citrate TEVA
- Sildenafil Citrate (GS)
- Tadalafil TEVA
- Tadalafil ACCORD
- Tadalafil DAILY
- Vardenafil TEVA
- Vardenafil ZYDUS
- Cialis
FDA passes on female Viagra patch
approval
2004-12-23
|
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.