Flibanserin will be used to treat low sexual desire in women.
Flibanserin, which is expected to be marketed under the trade name “Addyi,” is referred to as “female Viagra,” though that nickname isn’t quite accurate. Regardless, arrival of the medication in pharmacies in October is highly anticipated by many women who have hypoactive sexual desire disorder (HSDD). This condition is a lack of sex drive that cannot be attributed to relationship problems, mental health problems, or physical illnesses, and that causes personal distress. In other words, if you have no sex drive and don’t consider it a problem, you don’t have HSDD.
Flibanserin finally gained FDA approval on its third submission to the agency, after Sprout Pharmaceuticals, the North Carolina firm that owns the drug, submitted additional clinical data concerning how the drug affects driving and how alcohol affects those who take it.
What Do the Numbers Say About Sexually Satisfying Events?
Using an electronic journal, women in clinical trials for flibanserin recorded daily the number of sexual events they experienced, and for each, whether they considered it satisfying or not. A total of 543 women received flibanserin over a 24 week period, while 547 women took a placebo over a 24 week period. The mean standardized “sexually satisfying event” score increased by a factor of 2.5 with flibanserin versus a factor of 1.5 with the placebo.
What that means is, over a standardized 28-day period, women who took flibanserin had around two and a half times more sexually satisfying events compared to their numbers at the beginning of the trial. Women who took a placebo had around one and a half times more sexually satisfying events than their numbers at the beginning of the trial.
What Does “400% Better” Actually Mean?
An American woman named Amanda Parrish was one of the women who took flibanserin during the trial, and she was extremely pleased with it, saying her “sexually satisfying events” score increased by 400% after taking the drug for two weeks. That doesn’t necessarily mean she took the drug and soon she and her husband were having sex at every opportunity. Though Parrish’s exact numbers aren’t published, a 400% increase could mean that her baseline score was one sexually satisfying event in a month, and her score after taking flibanserin was 5 sexually satisfying events in a month.
For Parrish, the results were dramatically positive, and she became one of the chief supporters of FDA approval of the drug, testifying at various hearings and speaking to media. Not all women experienced results as dramatic as Parrish’s, but the increase in sexually satisfying events overall was determined to be statistically significant. What’s more, Parrish says when the trial ended and she had to stop taking the drug, her sex drive switched back off again, telling the UK’s Mirror, “As quickly as it started to take effect it wore off again.”
What Does Flibanserin Do?
The researchers who conducted the clinical trials for flibanserin hypothesized that HSDD was caused by “an imbalance in the excitatory and inhibitory activity that regulates the sexual response in the central nervous system” – a chemical imbalance among neurotransmitters in the brain. The “excitatory” neurotransmitters are dopamine and norepinephrine, while the “inhibitory” neurotransmitter is believed to be serotonin. When serotonin levels are too high and dopamine / norepinephrine levels are too low, sex drive plummets, according to the researchers’ hypothesis.
Flibanserin boosts the levels of dopamine and norepinephrine in the brain, while at the same time causing a transient decrease in serotonin. This rebalancing of brain chemicals is believed to be behind the increase in sex drive reported by women who took flibanserin.
Skepticism Still Abounds About Effectiveness
Not all the press surrounding flibanserin has been positive. In fact, the FDA hearings became somewhat of a lightning rod for arguments that flibanserin was a real feminist breakthrough (since drugs used to treat male sexual dysfunction have been around far longer) and for arguments that flibanserin was ultimately anti-feminist (by “medicalizing” a condition and medicating it so men could have more sex with their female partners).
Regardless of the political arguments surrounding flibanserin, clinical researchers were largely underwhelmed by the results. While users like Amanda Parrish reported a tremendous positive difference in their sex lives, not everyone did, and by and large the effects of flibanserin were subtle. Another concern of researchers is the fact that drinking alcohol while taking the drug poses a risk of fainting, hardly conducive to a sexually satisfying event.
Reasons the Search for “Female Viagra” Has Not Ended
Flibanserin may have been nicknamed “female Viagra,” but it works completely differently from Viagra and other medications designed for men with sexual dysfunction. The effects of alcohol in particular have been of concern. Since flibanserin is taken daily and long term, a woman must refrain from drinking alcohol however long she takes the drug because of the risk of fainting. For some women, this trade-off may be well worthwhile, but for others it may not be.
Another reason the search for female Viagra isn’t over is that unlike Viagra, which is taken on an as-needed basis, flibanserin is taken every day over a long period of time. As Amanda Parrish discovered, when the drug is discontinued, the effects go away too. Ideally, a “female Viagra” could be taken on an as-needed basis and would only be effective over the short term, the way drugs for men with erectile dysfunction do.
A drug called bremelanotide is given by injection and would be taken as needed to treat sexual dysfunction.
A company called Palatin Technologies is developing another drug called bremelanotide to treat “female sexual dysfunction.” This drug is in Phase 3 clinical trials currently, and is administered by subcutaneous injection. It is what’s known as a melanocortin agonist, activating existing melanocortin hormone pathways involved in sexual response. The Phase 3 studies are using a single-dose auto injector, which allows users to self-administer the drug, and which is how Palatin expects for the drug to be commercialized if it gains FDA approval. If the Phase 3 clinical data supports the effectiveness of bremelanotide, the company will then submit a New Drug Application to the FDA.
Bremelanotide is not taken regularly, like flibanserin is, but is used on an as-needed basis, which is likely to appeal to women who don’t like the idea of taking medication every day to treat low sexual desire. Another difference between bremelanotide and flibanserin is that bremelanotide may also be effective in treating erectile dysfunction in men.
Conclusion
Flibanserin may indeed have a significant positive effect on female sexual desire, and once the drug becomes available in October, we’ll be able to see how well it works in real world, non-clinical applications. But it is important to note that the “400% increase” in sexually satisfying events is not necessarily as monumental as it first sounds.
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