FDA panel delays approval of new female sex drug

Interesting...

Not enough safety data exists to OK patch, officials say

NEW YORK - A hormone patch that works to restore a woman’s sex drive should not win government approval until more studies are completed to determine the drug’s risks, federal health advisers recommended Thursday.

Several members of the Food and Drug Administration’s advisory committee said they were not satisfied with the number of women studied so far, the length of the studies and the modest benefits of the drug.

Procter & Gamble sought to market the testosterone patch Intrinsa to women who lost their libido after their ovaries were removed. The company told the committee that significant safety concerns had not come up in clinical trials and that there was no reason to delay approval of the first drug for female sexual dysfunction.