When Viagra became available to the public, men suffering from erectile dysfunction considered it a godsend, bringing the disorder out of the bedroom and into the public consciousness. Now drugmarkers are seeking approval for a women’s libido pill for the third time, facing hurdles in gaining approval along with plenty of controversy.
The drug in question is flibanserin, which some have dubbed pink viagra or women’s viagra. Made by Sprout Pharmaceuticals, the drug would likely go by the trade name Addyi if it gains approval. Like Viagra and Cialis, along with a variety of other medications, flibanserin treats sexual dysfunction. Viagra and Cialis help men to achieve an erection when aroused, but for women things are a little more subtle. The new drug is meant to target the brain, improving sexual desire. It is a selective serotonin reuptake inhibitor or SSRI, similar to antidepressants like Prozac.
Flibanserin treats something called Hypoactive Sexual Desire Disorder (HSDD), which is a low sex drive in pre-menopausal women. Proponents of the new pill say it is the most common sexual complaint among women, when their sex drive seems to lag behind that of their husband or partner. By some estimates, millions of women have the disorder, which can cause difficulties in a marriage or other relationship when one partner wants to have sex, and the other just does not have the desire and the physical readiness.
According to women’s health advocates, rejection of the drug twice equates to sexism with a double standard by the FDA. While twenty-six treatments have been approved to treat male sexual disorders like erectile dysfunction, there are zero treatments approved to help women. While men may have physical symptoms of a sexual disorder, like not being able to get or maintain an erection, for women it is usually more subtle. Some wonder if the FDA is even taking the female sexual disorders seriously.
For their part, the FDA maintains that rejecting flibanserin twice is not sexist. They have concerns about the drug’s effectiveness as well as its potential side effects. There are concerns that the drug could cause fainting, which could lead to injury especially if it was combined with alcohol. Flibanserin could also cause nausea, dizziness, and drowsiness.
When the FDA reviewed the new medication, they saw that there was a statistically significant improvement in the number of satisfying sexual events (SSEs). Women who took the drug in the trials also saw a reduction in distress related to low desire, when measured monthly. However, the differences between improvements from the drug and the experience of women taking a placebo were small, with about a 37% improvement with the drug versus the placebo. Because of this, the FDA was not satisfied so far that the benefits of the drug outweigh the risks, and there are also concerns about the drug’s safety with daily use. While male sexual dysfunction medications like Viagra also have risks and side effects, they seem to be outweighed by the benefits, according to the FDA.
Flibanserin was originally developed by pharmaceutical company Boehringer Ingelheim, but after rejection by the FDA in 2010, they sold it to Sprout. Other companies have also tried to gain approval for female sexual dysfunction treatments. Proctor & Gamble developed a testosterone patch for women which was rejected in 2004. BioSante’s testosterone gel failed clinical trials in 2011. Even Viagra’s maker Pfizer tried to develop a desire enhancing pill for women, giving up after many years because men and women are so different when it comes to arousal and desire. Some worry that with all these rejections for women’s sexual dysfunction medications, funding for research and development in women’s sexual health will, well, dry up.
The FDA’s external advisers will take a look at flibanserin for the third time on Thursday. Meanwhile, the controversy continues over whether the FDA is taking women’s sexual health seriously, or if there are legitimate concerns about the drug’s effectiveness and side effects.