To this day, there have been six drugs approved by the FDA for men who have difficulties getting an erection. On the other side of the fence, there have been zero drugs approved for women who have low libido. This is very unfortunate, especially given the fact that several million women in the United States have a low sex drive.
Why is that the FDA doesn’t pursue libido-increasing drugs for females? According to them, there is no gender bias taking place. Instead, it is believed that the complexity of sexual dysfunction is women is much more complex, which makes treating the qualifying disorders harder to treat.
There is one drug that is in its experimental stage, and it goes by the name flibanserin. For many who have tried it, they state “it was amazing, absolutely amazing, and it just makes you feel whole…It makes you feel like a complete woman again.” The FDA, however, will not give the green-light for the drug to be an approved treatment for female hypoactive sexual desire disorder.
Currently, Sprout Pharmaceuticals is trying to appeal the FDA’s decision. The drug itself has went through more than a few rigorous clinical trials, and it is very upsetting that the FDA will not give an approval. Dr. Iriwn Goldstein says if the drug does not get approved “It will go back to dark ages of saying, ‘This is all a relationship problem,’ even though we know it’s not.”
Sprout Pharmaceuticals submitted its application for the approval of flibanserin, providing data and information relating to 14 new clinical trials, which included more than 3,000 patients. Out of all the clinical trials completed on the drug, more than 11,000 people have been involved. Still yet, approval is not being given by the FDA.
Not receiving approval is coming as a surprise to many flibanserin advocates because data gives direct proof that “women taking the drug reported an average increase of 2.5 satisfying sexual events in four weeks, compared to an increase of [only] 1.5 among women using a placebo.”
Other drugs that are in the works for boosting a woman’s libido include Lybrido and Bremelanotide. Being that neither of the drugs have completed phase 3 trials, they are not eligible to apply for approval.