The story behind what has been branded as the ‘Female Viagra’ has been a rocky one.
This was the final stage of approval by the US Food and Drug administration. It was the third time the agency has considered approval for the drug, which is intended for women diagnosed with hypoactive sexual desire disorder, HSDD.
The Little pink table is intended to help women boost their sex drive.
Flibanserin, to be sold as Addyi, finally got a green light from the US Food and Drug Administration on Tuesday.
The drug, while often referred to as “female Viagra”, is more akin to an antidepressant as it changes brain chemistry similar to the way that dopamine and serotonin do.
Viagra relaxes muscles and increases blood flow to particular areas of the male body, helping treat erectile disfunction. While the blue pill for men should be taken before engaging in sexual activity, women are to take the pink pill daily.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). ”
The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”
But the FDA cautioned that care should be taken for potential adverse reactions to the pill, including low blood pressure and loss of consciousness.
“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” Woodcock said. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”
In June of this year, the pill took the first step to making it into US pharmacies. An FDA panel voted 18-6 in favor of approving Flibanserin on the condition that Sprout develops a plan to limit safety risks. The panel had previously rejected the pill twice before.
When the FDA rejected Boehringer Ingelheim’s application for Flibanserin in June of 2010, it ruled that the drug worked no better than a placebo.
“I certainly hope Boehringer doesn’t give up,” Sheryl A Kingsberg, a psychologist and Case Western Reserve University medical professor, told the New York Times at that time. “Flibanserin showed an awful lot of promise. I’m going to have some very, very disappointed patients if there’s nothing for them.”
Yet by October of that year, Boehringer did just that, announcing that it was discontinuing development of Flibanserin. Months later, in 2011, the drug was acquired by Sprout.
The pharmaceutical company tried its luck before the FDA in June of 2013, only to be thwarted when the agency ruled that the risks of sleepiness, dizziness, fatigue and nausea outweighed the benefits.
