Addyi can have significant side effects including nausea, dizziness and sleepiness. Women’s groups, including the National Organization for Women, signed on to the effort, though it was funded by Sprout and other companies working on female sex drugs.
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The FDA specifically approved the drug for premenopausal women with hypoactive sexual desire disorder, a lack of sexual appetite that causes distress.
Sprout’s CEO, Cindy Whitehead, told AP they would promote Addyi carefully. Sprout claims that flibanserin has a potential market of 16 million American women.
Women with insurance can expect to pay between $30 and $75 per month for Addyi, depending on the terms of their coverage. “This is game-changing for women”.
While the pill has garnered much attention under monikers like “pink Viagra” or “Viagra for women”, its goal and mechanism have little in common with the famous blue pill for men. In order to do that, this drug is taken daily and, over time, can affect the levels of certain chemicals in the brain. And there could be long-term risks from taking a psychoactive drug daily for years.
Originally developed by Germany’s Boehringer Ingelheim, flibanserin was first rejected by the FDA in 2010 after an advisory panel said the benefits did not outweigh the risks. The company also conducted several safety studies to more clearly define the drug’s risks, which are outlined in its warning label.
Sprout Pharmaceuticals was founded in 2011.
Some of that worry is pointed out by the FDA themselves in the press release announcing the approval, specifically the drug’s interaction with alcohol. In June, the independent advisory panel voted 18-6 to recommend approval for flibanserin, as long as the drug would also be subject to programs monitoring its safety.
– March 2013: Sprout resubmits the drug to FDA with additional data showing its benefits using a new measurement technique. The drug is meant to treat hypoactive sexual desire disorder (HSDD) in premenopausal woman.
Controversy surrounded the drug as critics have accused the FDA of gender bias for not approving any female sexual dysfunction drugs until now. Counselors say it is also the most hard to treat.
“The controversy is nearly irrelevant, because it has been approved as a safe and efficacious drug by the FDA”, Goldstein said. And, she said, as with depression, therapy can help but might not be enough.
“We live in a culture that has historically discounted the importance of sexual pleasure and sexual desire for women”, NOW President Terry O’Neill said in an NPR interview earlier this year.
Leonore Tiefer, a sex therapist who has been leading the New View Campaign against flibanserin and other drugs, said she was “disappointed but not surprised” by the FDA decision. The FDA continues to encourage drug development in this area. And the pill can be prescribed or dispensed only by doctors and pharmacists who watch an online slide presentation and pass a test of their comprehension.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
