Flibanserin is being touted as a treatment for low sexual desire in women.Raleigh, NC pharmaceutical maker Sprout Pharmaceuticals plans new clinical studies to address concerns of the US Food and Drug Administration (FDA) about the safety and effectiveness of the drug flibanserin.
The trials are expected to conclude before the end of the year, and represent the latest push by Sprout to overcome FDA objections to the drug, which is purported to treat low sexual desire in women.
Though sometimes referred to as “the female Viagra,” flibanserin works in an entirely different way than Viagra and similar drugs for men. While Viagra and other erectile dysfunction drugs in the PDE-5 inhibitor category address blood flow issues and are generally taken on an “as-needed” basis, Sprout claims that flibanserin increases sexual desire in women by altering brain chemistry. Specifically, the drug is said to raise levels of dopamine while lowering levels of serotonin. While there’s little debate that flibanserin does something, the FDA so far says it doesn’t do enough to offset the drug’s risks.
FDA’s Rejection of Flibanserin
Sprout Pharmaceuticals bought flibanserin from German drug manufacturer Boehringer Ingelheim in 2011. That company had abandoned development of the drug after trying and failing to gain FDA approval of it as an antidepressant and subsequently trying and failing to gain FDA approval for it as a treatment for low libido in women. Sprout has also tried and failed to gain FDA approval for flibanserin as a treatment for low female sex drive, but it hasn’t given up yet.
Sprout’s key clinical trial included over 1,000 women. The drug worked, but so did the placebo. Sprout reported that on average women taking flibanserin basically doubled the number of “satisfying sexual events” while taking the drug, while women taking a placebo reported a 50% increase in sexual desire. Sprout says this is statistically significant, but the FDA doesn’t think the benefit is significant enough to offset lack of long term data on safety and effectiveness for a drug that must be taken daily to have an effect. Additionally, around 15% of women in clinical trials dropped out due to side effects, which included anxiety, sleepiness, nausea and dizziness.
Is the FDA Sexist?
A number of women’s sexual health advocates say that the FDA denied approval of the drug not due to problems with its effectiveness and safety profile, but because the agency is sexist. While there are currently several drugs on the market for addressing sexual dysfunction in men, there are none addressing sexual dysfunction in women. Supporters of flibanserin (several of whom have worked as paid consultants for Sprout pharmaceuticals) say the FDA is simply squeamish when it comes to female libido.
A group of 62 doctors and medical experts recently wrote an open letter to the FDA questioning the lengths it is requiring Sprout to go to gain approval for flibanserin. The letter avers that the FDA is holding treatment options for women to a stricter standard of risk vs. benefit consideration than it has for drugs used to treat male sexual dysfunction.
Citing the fact that flibanserin has been studied for over a decade on more than 11,000 women, the letter questions FDA’s decision not to approve flibanserin. Rejection of the drug, which has “met its clinical endpoints in study and is worthy of approval by any other comparison of what has sufficed for the male drugs,” has made these researchers question the FDA’s commitment to female sexual health as compared to male sexual health.
Is Flibanserin a Drug Designed for a ‘Made-Up’ Condition?
Supporters of the FDA’s rejection of the drug claim that accusations of a sexist FDA are nonsense. Doctors, including Adriane Fugh-Berman, associate professor at Georgetown University Medical Center, say the buzz about flibanserin is mostly about marketing. Says Fugh-Berman, “It’s not sexist for the FDA not to approve a drug that it doesn’t believe is effective or safe.”
FDA supporters in the flibanserin approval saga say that Sprout has engaged in the marketing technique of creating a problem in order to sell a solution to it. They say that sexual desire varies from person to person, and within the same person during different phases of life, yet flibanserin is meant to be taken every day for a condition that is not necessarily considered a disease. Furthermore, flibanserin detractors say, the benefit from the drug was not that much better than the benefit from a placebo.
Supporters of flibanserin say that sexism is behind the FDA’s rejection of the drug.What Happens Next?
In February of this year, the FDA agreed to reconsider approval of flibanserin. As part of the agreement, Sprout Pharmaceuticals has agreed to conduct three more safety studies. Specifically, Sprout must complete studies to determine whether the drug impairs driving ability, whether it interacts with other drugs, and how the drug is metabolized in the liver. Sprout plans to submit results of these studies toward the end of 2014. If the FDA grants approval after submission of the safety studies, flibanserin could become available by prescription in 2015.
Conclusions
No one is denying that men have more options for treating sexual dysfunction than women do. And most medical experts agree that sexual desire in women is a more complex process than it is in men. The FDA has rejected numerous drugs targeted for increasing sexual desire in women, including testosterone patches and gels, as well as PDE-5 inhibitors like Viagra in women. The FDA doesn’t believe the long term safety of testosterone treatments has been demonstrated, and says that Viagra simply doesn’t work in women.
Flibanserin addresses low libido in women in a completely different way than other drugs have attempted to, and it has encountered many hurdles along the road to FDA approval. Now it’s a matter of waiting and seeing if Sprout’s safety studies are enough to sway the FDA in their favor.
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