The National Women’s Health Network (“the Network”) urges the FDA to oppose the approval of Sprout Pharmaceutical’s female sexual dysfunction drug flibanserin. The Network has come to this position after careful consideration of newly disclosed research and thorough evaluation of the drug’s extensive and troubling safety and efficacy.
“We recognize that a lack of sexual desire can be a distressing problem for women. We also believe that it might be possible to develop a drug that is effective for some of women’s sexual problems. However, based on our review of the data about flibanserin, it’s clear the problem with this drug is not gender bias at the FDA but rather the drug itself,” says Cindy Pearson, Executive Director of the National Women’s Health Network.
Women rely on the FDA to ensure that any drugs or devices marketed to and used by them are both safe and effective. Approval of flibanserin should only be based on careful consideration of a risk-benefit analysis, with proof of effectiveness weighed against a reasonable safety profile. Some may argue that even very small improvements are enough to justify FDA approval. But in this case, significant known and unknown adverse reactions, drug-drug interactions, and side effects outweigh the drug’s benefits.
Given the reported adverse events, strong placebo effect, and the higher dropout rate in the flibanserin arm of all three pivotal trials, many unresolved questions remain about the seriousness, severity, duration, and frequency of side effects with flibanserin.
Furthermore says Pearson, the “FDA asked the sponsor to conduct a study of alcohol and flibanserin because alcohol increases the potency of this class of drugs. But Sprout only included two women in their study. Women deserve answers to important safety questions based on research that actually includes women.”
The fact remains that Sprout has not provided enough data for women to make an informed decision. It is for those reasons that the Network strongly recommends that the FDA not approve flibanserin without further studies assessing its safety.
The National Women’s Health Network is supported by our members and by choice, we do not accept financial support from drug companies or medical device manufacturers. We bring the voices, concerns and needs of women consumers to policy and regulatory tables.