The approval of the controversial drug, flibanserin, which the FDA twice rejected before and now will be marketed as Addyi, comes with a series of conditions reflecting the agency's concerns about serious side effects. These include a boxed warning that highlights the risks of low blood pressure and fainting in patients who drink alcohol while taking the drug, as well as a requirement that doctors complete a training course before being allowed to prescribe it.
"Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment."
Supporters of the drug hailed the decision as an end to what they called "gender bias" at the FDA, giving women more choice and control over their sexual lives. Critics said the approval of what some call a "mediocre aphrodisiac" with significant side effects has now turned the normal range of women's low sexual desire into a disease, with pharmaceutical companies only too eager to rush in.
The FDA is requiring the drug manufacturer, Sprout Pharmaceuticals, to conduct three studies in women to better understand the serious known risks of the interaction between Addyi and alcohol.
The pill is intended to treat a condition called Hypoactive Sexual Desire Disorder, or chronic and distressingly low libido in pre-menopausal women that cannot be explained by factors such as relationship troubles, stress, or medical or psychological issues.
The FDA recommends that women stop using the pill if they notice no change in their libido after eight weeks.
Cindy Whitehead, Sprout's chief executive, said that the company has prepared an online training course for prescribers and that the drug will be available as soon as Oct. 17. The company will refrain from advertising directly to consumers for 18 months, she said, to avoid creating a clamor for the new drug.
"This is really a milestone moment to celebrate," Whitehead said. She has fought for the drug's approval - mobilizing women's groups, organizing and funding a high-profile marketing and lobbying campaign called Even the Score, and publicizing the stories of women with distressingly low libidos - since Sprout acquired flibanserin in 2011. "There hasn't been a whole lot of innovation in this category of women's health since the birth-control pill [in 1960]. This is game-changing for women."
Unlike Viagra, which was approved by the FDA in 1998 and increases blood flow to the genitals, flibanserin targets neurotransmitters in the brain. Though just how the drug boosts desire remains unknown, flibanserin affects the levels of dopamine and norepinephrine in the brain, neurotransmitters that are key to sexual desire, and serotonin, which governs inhibition.
Also unlike Viagra, which is taken on an as-needed basis, flibanserin is effective only if taken every day. Because the drug can cause sleepiness, Sprout recommends taking it before bed.
Adriane Fugh-Berman, a pharmacology professor at Georgetown University and director of PharmedOut, which focuses on pharmaceutical marketing practices, called Tuesday "a sad day for drug regulation."
"The FDA turned down this drug twice because the risks outweighed the benefits," she said. "What has been learned since the last disapproval is that it has more risks than we thought and it doesn't have any more benefits. The only thing that's different is a clever, aggressive public relations campaign that Sprout Pharmaceuticals waged successfully."
She added: "This opens the way for drug companies to pressure the FDA through public relations campaigns to approve more bad drugs: It's bad news for rational drug approval."
The FDA rejected the drug in 2010 and in 2013, saying the risks of side effects such as nausea, dizziness, low blood pressure, fainting and sleepiness outweighed the "modest" benefit. In June, however, an FDA advisory panel voted 18 to 6 to recommend approval. That vote came after Sprout conducted additional safety testing and measured the drug's impact on sexual desire over 28 days, not daily as in earlier studies. The FDA concluded there was a "statistically significant" improvement over a placebo.
Prior to flibanserin, there had been no FDA-approved treatments for Hypoactive Sexual Desire Disorder, first described in medical literature in 1977.
Surveys show that low libido is the most common female sexual dysfunction. Counselors say it is also the most difficult to treat.
Sally Greenberg, executive director of the National Consumers League and a member of the Even the Score advocacy campaign, praised the FDA decision. "It acknowledges that as a condition, HSDD is not simply a psychological problem or a reflection of cultural pressure on women but a biological condition that can be treated with an effective medication," she said.
Marianne Brandon, a sex therapist in Annapolis who served on the FDA advisory panel and voted to recommend approval of the drug, said low desire, like depression, is physiological as well as psychological and emotional. And, she said, as with depression, therapy can help but might not be enough. "Turning low libido around, without having a biological component to your treatment like a flibanserin, is difficult," she said.
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.
"It's interesting that the FDA made it so you're going to have to jump through quite a few hoops to get this drug," she said. "They're asking health-care professionals to assess the likelihood of the patient reliably abstaining from alcohol. Well, that's asking too much, if you ask me."
Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, sat on the FDA advisory panel and voted against approval of the drug. More than half of pre-menopausal women drink regularly, he said, citing testimony at the June hearing, and 30 percent report binge drinking. "Given the prevalence of alcohol use and abuse in our society," he said, "I think it's alarming that this product's interactions with alcohol aren't better explored before it's approved for the market."
Alexander said one of the main differences in the FDA's previous rejections of flibanserin and its approval Tuesday was the high-profile Even the Score campaign, which ran TV ads, lined up several members of Congress and gathered more than 60,000 signatures to press the FDA to approve the drug.
Whitehead said Sprout has already completed studies to test the effectiveness of the drug in post-menopausal women - a potentially huge market, with the growing number of aging female baby boomers. Libido naturally drops with age as hormone levels fall. The company will begin working toward FDA approval for older women, Whitehead said. "This could have a real-life impact and be a real change for them," she said.
FDA analysis of the outcomes of flibanserin clinical trials found "small but statistically significant" improvement in sexual desire and satisfying sexual events, and lower levels of distress.
"Our goal is not to move someone who rarely or never has interest in sex to wanting sex most or all of the time," Whitehead said. "We're aiming to bring her back into normal range."
That's all Katherine Campbell, 31, a mother of two young boys in Noblesville, Ind., says she wants. She said when she heard the news about the FDA approval, she started to cry. "Oh, my gosh, I'm so excited. I cannot wait to try it," she said. "I know millions of other women are out there waiting to get their hands on it, too."
After having a healthy sex life and often a higher sex drive than her husband in her 20s, Campbell said her libido disappeared after the birth of their first child three years ago and has never returned. "It literally changed overnight," she said. "It's been really tough on our marriage. My husband and I still had sex, but it was more out of obligation."
And if flibanserin does not work, there are several other drugs aimed at boosting women's craving for sex already in the FDA pipeline.
Carl Spana, president and CEO of Palatin Technologies, said the FDA approval was "a big positive" for drugs such as the one his company is developing, bremelanotide, which works on melanocortin receptors in the brain to boost female sexual desire. "Women need other treatment options," he said. "The decision really sets a regulatory precedent for how the FDA will measure efficacy moving forward."
Spana hopes to submit the drug for FDA approval in 2017 and put it on the market by 2018.
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