FDA Advisors Recommend Approval of Women’s Libido Drug
On Thursday, an advisory panel recommended to the United States Food and Drug Administration that they approve the first medication designed for premenopausal women with low libido, but only if special safety precautions are included.
In an 18 to 6 vote, the approval was a victory for Sprout Pharmaceuticals, which has pushed the drug known as flibanserin, with a proposed name of Addyi, despite two previous rejections by the FDA. After the last denial in 2013, the company created an Internet based advocacy campaign known as eventhescore.org that accused regulators of sexism and a double standard.
In a statement after the vote, Sprout said that "we look forward to continuing our work with the FDA."
The FDA is expected to act on the recommendations by September and historically follows the recommendations of its advisors. However, the vote was a blow to a coalition of women's health activists who believe the FDA was right the first two times it denied the drug saying that the risks of flibanserin, that include drowsiness, fainting and low blood pressure, don't outweight the marginal effectiveness.
Cynthia Pearson, head of the National Women's Health Network, said the panel's daylong meeting showed the "many unresolved questions about the seriousness, severity, duration, and frequency of flibanserin's side effects," which can be worsened by "alcohol, birth control pills, and a host of other drugs."
Even the FDA's advisors who voted for approval expressed ambivalence toward the drug.
"The benefits are modest, maybe less than modest, but I'm afraid that puts [flibanserin] in good company with other approved drugs," says adviser Walid Gellad, codirector of the University of Pittsburgh's center for pharmaceutical policy. "I also have serious safety concerns."
Because of those concerns, the panel urged the FDA to strengthen product label warnings for the drug by requiring patient education programs and a certification program for doctors who plan to prescribe the drug to patients.
Sprout has stated that its own labeling should advise women to quit the drug if it doesn't work within 12 weeks. The company also promised not to do any direct to consumer marketing for the first 18 months, to let doctors learn more about the drug.
In clinical trial, the drug only showed marginal improvement enhancing the libido in women by one more than the placebo.
Leonore Tiefer, a New York University psychiatrist and sex therapist who has harshly criticized the drug and eventhescore.org, said she hopes the FDA overrides the panels recommendations.
"It's a triumph of emotion over science," Tiefer says. "I think the committees were persuaded by the doctors who said they had 'nothing' to offer their patients. Absurd."
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