'Female Viagra' to be approved
2004-12-02 20:13
Washington - A skin patch providing sexual stimulation for menopausal women that promises to do what Viagra did for men will begin its approval procedure on Thursday at the Federal Drug Administration (FDA).
The brainchild of Procter and Gamble (P and G), the Intrinsa patch delivers the male hormone testosterone - chief sexual stimulant in both sexes - through the skin to women undergoing menopause or whose ovaries have been removed.
P and G has conducted four clinical trials with Intrinsa on 2 200 women providing 12 months of data on the efficiency of the hormone-replacement treatment and its possible health risks.
An independent panel experts at the FDA, which vets and approves drugs for the US market, will hear the pros and cons of Intrinsa during a public audience on Thursday.
Mostly made up of gynaecologists, the panel will make its recommendations on the patch for an FDA decision a month or so later.
Side effects mild
"We believe we have a strong clinical programme studying the safety of this patch and that millions of surgically menopaused women may benefit from an FDA approval," said P and G spokesperson Elaine Plummer.
"The side effects we saw were very mild," she said, noting that in some women aged around 49 Intrinsa caused upper respiratory infection like a cold, and unwanted facial hair.
"No one discontinued the study because of that," Plummer said, adding that the majority of the women who participated were very satisfied with the results.
"They all experienced significant improvement in arousal, orgasm, responsiveness, improved self-image and decreased stress level," the spokesperson said.
According to Dr Andre Guay, an expert in sexual function at Lahay Clinic in Burlington, Massachusetts, Intrinsa "would be the first patch like this for women to be approved."
"The significance of this patch coming to the market is much more than a company putting out a product to make money," he added. "This is the first country and the first regulatory agency to acknowledge that women have testosterone deficiency."
Same 'goal' as Viagra
Intrinsa's advent will open the financial coffers for more research in the field, Guay said, cautioning that the patch has "nothing to do with Viagra, but the goal is the same."
He predicted an intense debate on Thursday by the FDA panel, whom he said include conservative experts appointed by the administration of President George W Bush and liberal-minded ones.
"I am not sure they will recommend it because of Vioxx," Guay said referring to the anti-inflammation drug recently withdrawn from the market due to its high risk for heart disease.
Even if P and G's Intrinsa meets FDA approval, the federal agency could delay authorising its sale for a year demanding additional tests for safety and to avoid another barrage of criticism from Congress after it was blamed of being too lenient with pharmaceutical companies over the Vioxx scandal, Guay said.
In his opinion, Guay said, "the patch is safe because the level of testosterone is low."