Flibanserin, the female libido booster that was rejected by the Food and Drug Administration (FDA), may be about to help women out of a sexual rut this year. Sprout Pharmaceuticals, the privately held developer of the drug, says the FDA has requested three additional studies. Two of those include a study to test the drug’s interaction with other medication and with a third study, the FDA wants results on how flibanserin affects the driving ability.
Flibanserin was once under development with Boehringer Ingelheim, but Sprout Pharmaceuticals, a company led by a husband and wife, acquired the drug after Ingelheim received a first rejection back in 2010. In the rejection letter, the FDA expressed concerns with regards to the drug’s lackluster effectiveness and its side effects of dizziness, fatigue and nausea. The Sprout Pharmaceutical couple from Raleigh, North Carolina; however, believes in the drug and has been passionate about its development since acquirement. The couple says they are luckily not the only one.
In January, several women’s advocacy groups met with the FDA’s head of pharmaceutical division, Dr. Janet Woodcock. The women’s advocacy groups, including the National Council of Women’s Organizations and the Center for Health and Gender Equity, stated that the requirements for approval of flibanserin exceed the requirements for male erectile dysfunction drugs. According to the advocacy groups, the approval process of flibanserin therefore seems to be more of a political issue rather than a health issue, with previous studies proving that it can help women out of a sexual rut.
In the meantime, some female members of Congress have been part of the discussion as well, urging the FDA to give flibanserin a careful review and to apply the same standards of consideration given to drugs that were approved for male erectile dysfunction.
Cindy Whitehead, president of Sprout Pharmaceuticals, is happy with all the support flibanserin has been getting and considers the requested studies from the FDA as the next step in the approval process. She also says the studies are relatively small, involving 25 to 50 women per study, but that the FDA must understand the purpose of the drug. Whitehead explains, “Flibanserin does not cause hypersexuality in women, but hypersexuality is not what we are after. Therefore, the drug does not have a lackluster effectiveness. We are aiming for modest on purpose.”
If approved by the FDA, flibanserin will be the first drug on the market for women who report to have a lack of sexual drive. In addition, Sprout will have to convince doctors to prescribe the drug to women. Sprout considers this as a next challenge, as the condition is not widely acknowledged by medical doctors. The first drug for men with erectile dysfunction, Viagra, was approved by the FDA in 1990.
Whitehead is convinced that flibanserin is about to help women out of a sexual rut and states Sprout will resubmit its application at the FDA in the third quarter, after it completes the FDA’s three additional studies in the second quarter. Flibanserin is mainly advised for premenopausal women with hypoactive sexual desire disorder.
By Diana Herst
The Washington Post