A sex drive drug called flibanserin, which is specifically designed to boost a woman’s libido, has been delayed by the FDA due to more evidence that is needed to prove its effects and safety. The intended drug was to be a woman’s legitimate answer to Viagra, intended to aid women with low sexual desires. Despite the denial by the Food and Drug Administration (FDA), Sprout Pharmaceuticals has stated that they will not give up on the drug just yet.
The FDA has required Sprout Pharmaceuticals to complete three human studies of flibanserin in a study to determine whether the drug is safe and does what it actually is intended to do. The three studies required for flibanserin only require a small test group of 25-50 patients in order to be considered for approval. More research data is wanted by the FDA to further display how the drug reacts with other drugs in the body, whether it causes sleepiness, and if it impairs driving in any way. In studies already completed on the drug, 10 percent of women expressed that they experienced sleepiness.
“We are encouraged by the FDA’s response and view it as a significant step toward the approval of flibanserin,” Sprout Pharmaceuticals said in a statement. The FDA responded to the news of the delayed drug by stating, “Any information on an application that has yet to receive an approval or was denied approval belongs to the manufacturer/sponsor developing the drug.”
The pharmaceutical industry has been trying to successfully develop a female sex drive drug for 15 years, but the recent delays of flibanserin by the FDA implies that it might take a while before it could be in the market. The drug designed for women is different because it tries to “increase sexual desire by acting on brain chemicals that affect appetite and mood.”
The sex drive for women is much more complicated than it is for men, according to professionals. Factors that significantly affect a woman’s sex drive can include non-medical factors such as stress, relationship issues, and lifestyle choices. Other issues can also factor into causing low sexual desires in women, and they can affect those going through issues such as menopause, recent childbirth, and illness.
A husband and wife teamed up to form Sprout Pharmaceuticals in 2011. The married couple acquired flibanserin from the large pharmaceutical company, Boehringer Ingelheim, who had trouble getting the sex drive drug for women off the ground. The first wave of research conducted by Boehringer Ingelheim concluded that flibanserin only moderately improved “sexually satisfying events.” The FDA made a similar decision to Boehringer as they recently did to Sprout, in which the company had to provide more data and research through testing.
Even though the delays of the sex drive drug for women can be seen as a momentous step in approving flibanserin, Sprout Pharmaceuticals will take some time in properly researching and testing the product for the FDA’s approval. Doctors still have to choose to prescribe flibanserin to patients, but the drug has to be approved for this to even happen. Sprout Pharmaceuticals is aiming to resubmit flibanserin for FDA approval in the third quarter of 2014, after the three new studies are complete.
By Glen Parris