FDA to Decide Today Whether 'Female Viagra' Can Be Marketed
The FDA, which is weighing to approve the drug on Friday, said that women who took the daily-dosed drug experienced significant side effects, including depression, fatigue and fainting.
But worse, the FDA claims the drug failed to boost women's libidos in studies of more than 2,400 women, who were treated with either flibanserin or a placebo.
Women in both groups showed a hike in the number of sexually satisfying events but didn't show any increase in sexual desire. Side effects forced about 15 percent of the women to stop taking the drug, twice as many women as in the placebo group.
The drug's maker, Germany-based Boehringer Ingelheim, said that the drug provides an option for women with what doctors call "hypoactive sexual desire disorder," noting that current options are "extremely limited." According to Boehringer Ingelheim, women must take the drug on a daily basis for its sexual promises to take effect.
If the FDA's panel of experts approves flibanserin on Friday, the drug company stands to gain about $2 billion in profits, equal or greater than annual sales of the three top men's sex drugs, Viagra, Levitra and Cialis.