FDA advisory committee recommends approval of controversial 'female Viagra'
An advisory committee to the Food and Drug Administration voted today to back the approval of a drug meant to boost the libido of women who struggle with decreased sex drive. In an 18-6 vote, the committee decided to recommend that the FDA approve the drug, Flibanserin, given certain labeling and risk management conditions, The Washington Post reports.
Flibanserin, developed by Sprout Pharmaceuticals, works by boosting the response of receptors in the brain to chemicals like serotonin and dopamine. It's suggested for women who suffer from Hypoactive Sexual Desire Disorder, a condition described at the advisory meeting as feeling like "a switch had gone off."
"A challenging risk / benefit assessment"
But there are concerns about the drug, which the FDA has described as having "a challenging risk / benefit assessment." Sprout Pharmaceuticals said that in a 24-week clinical trial, 46 to 60 percent of women benefitted from the treatment, but detractors argue that if the placebo effect is taken into consideration only 10 percent of women actually benefitted. Other trials saw a negligible increase in the amount of sex couples had while one partner was taking Flibanserin. One trial saw an increase from only two to three times per month, New Scientist reports. The FDA panel described the drug's benefit as "moderate" or "marginal," the Post reports.
There are risks beyond the fact that the drug might just not work. Flibanserin has been found to interact poorly with alcohol and birth control pills, leading to side-effects like fatigue, dizziness, and nausea. A two-year study of the drug found an increased breast cancer risk in mice who were given four times the therapeutic dose of 100 milligrams per day.
Despite the fact that Flibanserin has not been proven to be wholly beneficial, some doctors who testified at the FDA committee hearing today argued it was better than nothing. One medical practitioner said when female patients come to her looking for help, she has no real solutions to offer them. "This is all I can tell them," she said, according to the Post. The FDA approved the commercial use of Viagra in 1998, but it has yet to approve a similar libido booster for women. Viagra did try to expand its use to women in 1999, but it didn't work the same way it did for men.
Some argue it's better than nothing
Impotence in men is not the same thing as low sex drive in women. Though men and women can both see a decrease in sex drive due to a number of factors, low sex drive in women tends to be more closely related to stress and relationship issues, AP reports. And whereas Viagra increases blood flow to the genitals, Flibanserin alters chemical function in the brain. Unlike Viagra, Flibanserin would need to be taken daily, regardless of whether or not the woman taking it wanted to have sex that day.
Flibanerin has been rejected by the FDA twice before, in 2010 and 2013, but Sprout Pharmaceuticals has continued to aggressively resubmit the drug. The advisory committee will now work on setting the conditions that will need to accompany FDA approval.