Thursday’s endorsement by the advisory panel was somewhat muted, with the committee calling the drug’s benefits “moderate” or “marginal,” the Post reported.
The FDA typically follows the recommendations of its advisory panels, but is not bound to do so. Formal approval of the drug could come by the end of summer, the newspaper said.
The refiled application for flibanserin followed a strong lobbying effort by women’s groups, consumer advocates and politicians who support approval of the daily pink pill for sexual dysfunction, theAssociated Press reported. There is no drug on the market for women with low libido, and drug companies have been trying to get one approved since Viagra’s successful introduction for men in the late 1990s.
In a statement before the panel convened Thursday, Cindy Whitehead, CEO of flibanserin maker Sprout Pharmaceuticals, said, “The review of flibanserin … represents a critical milestone for the millions of American women and couples who live with the distress of this life-impacting condition without a single approved medical treatment today,” according to an NPR report.
Flibanserin, which would be sold under the brand name Addyi if granted final approval, shifts the balance of the brain chemicals dopamine, norepinephrine and serotonin to treat what is called “hypoactive sexual desire disorder,” or HSDD, in premenopausal women.
Viagra, on the other hand, works by increasing blood flow to the male genitals.
In clinical trials conducted by Sprout, women whose average age was 36 took the medication for five months and reported an increased sexual desire, reduced distress and an increase in “sexually satisfying events” compared with women taking a placebo, the Los Angeles Times reported.