The arduous journey of a women’s libido-enhancing drug appears headed for marketing approval. A Food and Drug Administration (FDA) advisory panel recommend conditional approval of flibanserin, which has been termed “Women’s Viagra”. For the past decade, drug manufacturers have been searching for a female equivalent of Viagra, and the recommendation marks a significant, but cautionary step in that direction.
The government panel recommended approval for a pill to boost sexual desire in women; however, the green light comes with reservations because of reported side-effects such as fatigue, low blood pressure, drowsiness, and fainting. The panel voted 18-6 in favor of Sprout Pharmaceutical’s pill, flibanserin, on the condition that the company develops a strategy to manage its risks. The glow of victory that comes with the approval is dampened by years of concerns regarding both safety issues and lackluster effectiveness. Since 2010, the FDA has twice denied approval of flibanserin. The FDA does not have to accept the panel recommendation; however, the agency usually heeds panel decisions.
The FDA panel noted that the drug’s effect is rather weak, but a need exists for FDA-approved drugs to address female sexual problems. “These are very modest results,” noted Dr. Julia Heiman of the Kinsey Institute at Indiana University. She added, “But on the other hand, even modest results can make a lot of difference when you’re at a certain point in the clinical problem.”
Most of the women involved in the clinical study reported between 0.5 and 1 more sexually satisfying event per month, compared with women taking a placebo. In addition, they scored higher on questionnaires measuring desire and scored lower on measures of stress. Flibanserin is a selective serotonin reuptake inhibitor (SSRI), which is a member of a class of drugs such as Prozac to treat depression. It was originally developed as an antidepressant but was found to be ineffective. However, during the study for its antidepressant effects, women reported a boost in libido. Interestingly, Viagra was initially under development as an antihypertensive (blood pressure lowering) agent. During that evaluation, improvement in erectile dysfunction was reported.
