The drug, Addyi, also known by the generic name of flibanserin, is produced by Sprout Pharmaceuticals.
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The agency is requiring a warning that people who drink alcohol, have liver problems or take CYP3A4 inhibitors not take the drug. The pill will only be available through certified health care professionals and certified pharmacies.
STEIN: The FDA had rejected the drug twice before, saying there wasn’t enough evidence it worked and there were worries about its safety.
“This is a triumph of marketing over advocacy”, said Cynthia Pearson, head of the National Women’s Health Network.
“So many hoops to jump through”.
“If someone has low sexual desire because they hate their partner, sex hurts and their life is a mess… the pill is not going to help them”, said Dr. Lauren Streicher of Northwestern University.
CHRISTINE KEARNEY: She and others argues Sprout successfully manipulated the debate around the drug into one of women’s rights, rather than health.
This is the biggest advance in women’s health since the pill. Kingsberg wrote in an email.
“It’s beyond ridiculous that this is being called “female” Viagra, ‘” Bat Sheva Marcus, a sexual-dysfunction specialist at the Medical Center for Female Sexuality in New York, told Business Insider.
The drug will be produced by Sprout Pharmaceutical and is the first of its kind for women, as for men Viagra has been available for decades. The FDA changed that to eight weeks.
Currently, there is nothing on the US market approved for treatment of HSDD or another condition, female sexual interest/arousal disorder (FSIAD). “This isn’t about blood flow”.
After years of men having a medication that they can use when experiencing low-libido or other causes of erectile dysfunction, the United States Food and Drug Administration has finally approved a similar medication for women to use as of late today.
While mid-stage clinical trials of flibanserin failed to show efficacy in treating depression, Boehringer Ingelheim noted that patients in the studies noted improvement in their sex drive.
Although it was effective in trials in raising the number of times a woman has satisfying sex (which the scientists label “satisfying sexual episodes”) it didn’t improve sexual desire – the very thing the drug was created to do. In Dr. Tiefer’s view, the problem stems more from “hopelessness, self-critical feelings and lack of confidence”.
June 2010: A panel of FDA advisers votes unanimously against the drug, saying its benefits are outweighed by its risks, including side effects like dizziness, fatigue and fainting.
Bob and Cindy Whitehead, the owners of Sprout Pharmaceuticals, have a history of running afoul of FDA regulations, critics of the company have pointed out.
A public relations campaign called Even the Score lobbied Congress and the FDA for approval. However, there is a major push to somewhat level the therapeutic playing field for women, many of whom look at Viagra for men and wonder, “Why is there no option for my low libido?” Many women testified they had lost interest in sex and experienced difficulties in relationships as a result.
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The FDA has consistently denied gender bias.
