For the first time, women will have a drug to treat low sexual desire.
The Food and Drug Administration approved Sprout Pharmaceuticals’ female libido drug flibanserin on Tuesday. The once-daily treatment, which will be known commercially as Addyi, is intended to improve sexual desire among premenopausal women.
Controversy surrounded the drug as critics have accused the FDA of gender bias for not approving any female sexual dysfunction drugs until now.
But critics of the drug say it is not safe, noting that the agency rejected it twice before. However, new safety data and an agreement for further patient protections seem to have swayed the agency.
A coordinated lobbying campaign was started to win approval for the drug. The industry-funded group Even the Score pointed out that there are 26 drugs to treat sexual dysfunction in men but none in women.
Members of Congress also weighed in. A letter from 11 House lawmakers sent to the FDA earlier this year pointed out the disparity in dysfunction drugs.
The drug was backed by a majority of FDA advisers during a meeting earlier this summer. While the advisers recommended approval, they did say that extra protections needed to be established to protect patients.
The agency heeded the advisers’ call.
“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”
Critics have charged that the group, supported by Sprout and Tiramel Pharmaceuticals, blatantly overlooked the safety concerns with the drug.
“Even the Score is not a grassroots feminist movement: It is an industry-funded social media campaign to promote flibanserin,” according to a fact sheet from PharmedOut, a Georgetown University Medical Center project that takes aim at pharmaceutical marketing practices.
Sprout previously told the Washington Examiner that 26 other groups and industry organizations support it, including the National Organization for Women.
PharmedOut had serious qualms with the drug.
“The harms and narrow margin of safety of flibanserin might be acceptable in a cancer drug, but are entirely unacceptable in a drug given to healthy women for a questionable condition,” the group wrote in a letter to the FDA. “Low libido can be effectively treated by therapy.”
Sprout said Tuesday night it expects the drug to be available in October.
