14 DAY TRIAL // Just yesterday, June 4, members of the US Food and Drug Administration's Bone, Reproductive and Urologic Drugs Advisory Committee and the Risk Management Advisory Committee met to review a new drug developed by Sprout Pharmaceutical.
The experimental compound, which goes by the name of Flibanserin, promises to boost women's libido. Hence, it is sometimes referred to as the female Viagra or Viagra for women.
Since 2010, the US Food and Drug Administration has rejected it on two different occasions on the grounds that the risk of negative side effects outweighed its potential benefits.
During yesterday's meeting, however, representatives of the agency's Bone, Reproductive and Urologic Drugs Advisory Committee and Risk Management Advisory Committee voted 18-6 in favor of granting Sprout Pharmaceutical approval to market Flibanserin.
The Food and Drug Administration will now assess the drug itself and should deliver an official decision on whether or not it will green-light sales sometime this coming August.
“We are pleased with the positive outcome of today's Advisory Committee meeting and the confidence that was expressed,” said Cindy Whitehead, chief executive officer, Sprout Pharmaceuticals.
The side effects are still there
The advisory panel to the Food and Drug Administration agreed to back Sprout Pharmaceutical's drug on condition that the company develop and implement safety restrictions intended to better manage and limit potential side effects.
These side effects that health experts want Sprout Pharmaceutical to do a better job mitigating and warning people against include low blood pressure, fatigue, nausea, dizziness, sleepiness and fainting.
The company insists that, having tested the drug in several clinical trials involving over 11,000 women, it didn't find cause to stop making it. Au contraire, they say that, most of the time, the side effects they documented were mild.
So, how does the drug work?
Unlike Viagra, which merely increases blood flow, Sprout Pharmaceutical's Flibanserin is designed to alter brain chemistry. The brain region that it targets is the prefrontal cortex.
“It increases dopamine and norepinephrine (both responsible for sexual excitement) while transiently decreasing serotonin (responsible for sexual satiety/inhibition) in the brain's prefrontal cortex,” the company explains the drug's effects on the brain.
Interestingly, Flibanserin was first developed as a treatment for depression. Sprout Pharmaceutical now wants to make it available for premenopausal women diagnosed with hypoactive sexual desire disorder (HSDD, for short).
The company explains that women diagnosed with this condition, which was officially recognized by the medical community over 40 years ago, show very little interest in intimate relations and also have very few or even no sexual fantasies.
Of the women suffering from HSDD, many experience distress and have trouble interacting with others, Sprout Pharmaceutical says. According to the company's estimates, about 16 million women in the US alone are affected by HSDD.