Forty-three percent of women suffer from sexual dysfunction, while only thirty-one percent of men do. However, there are over two-dozen different drugs available to men to help them with their sexual needs. One out of every ten women on the other hand have zero drug options for help in that region.
On May 4th, a cure for female sexual dysfunction was on the chopping block for the third time in front of the Food and Drug Administration (FDA) advisory committee. The drug, flibanserin is often referred to as “the female Viagra.” It was unanimously voted against by the FDA during a 2010 hearing, for side effects which outweigh the effectiveness such as sleepiness, dizziness, nausea, and safety risks like a loss of consciousness and low blood pressure.
However, Thursday’s meeting concluded with the FDA panel voting 18 to 6 in favor of flibanserin, on the condition that the manufacturer develops a new plan to limit the safety risks.
Sprout Pharmaceuticals designed flibanserin for the daily use of premenopausal (typically 48 years old and younger) women whose loss of desire is not the result of a disease or side effects from another drug. The drug temporarily decreases serotonin in the brain while raising the levels of dopamine and norepinephrine and is meant to be taken during bedtime.
To win over the FDA’s approval, Sprout Pharmaceuticals conducted a new study to demonstrate that the drug will not impair driving. If the advisory committee denied approval once again, they were at risk of facing a vast amount of criticism.
The Even the Score campaign, created to help “even the score” of sexual dysfunction drugs for women, started an online petition with around 40,000 signatures supporting flibanserin. Many supporters of the drug accused the FDA of having a gender bias towards women. With over 25 male sexual dysfunction drugs approved by the FDA, despite hazardous side effects such as blindness and penile rupture, one does wonder why advisors were so quick to deny the approval of any female sexual dysfunction drug.
This FDA approval is a huge step forward for flibanserin, but the fight is not over just yet. It is not guaranteed yet that pharmacies will start stocking the drug. The FDA may still deny the drug during its final decision and it could be weeks or months before we find out.
Check out this video made by The Even the Score campaign’s project, #WomenDeserve.