‘Pink Viagra’ backed by FDA panel
WASHINGTON — American women may soon have access to a controversial libido-enhancing pill dubbed “pink Viagra” after a government panel on Thursday gave its backing to what would be the first FDA-approved drug for the treatment of female sexual dysfunction.
In an 18-6 vote, a panel of Food and Drug Administration experts recommended allowing the experimental drug, flibanserin, to be sold in the U.S. as long as certain safety precautions are taken to minimize potential side effects, which include low blood pressure, dizziness and fainting.
Some say drugs like flibanserin could enhance women’s sex lives in the same way erectile-dysfunction medications have improved men’s. But experts in female sexuality scoff at the notion that a 100-milligram pill, taken daily at bedtime, will turn women’s sexual desires on with the ease of flipping a light switch. In clinical trials, the drug had a small but measurable effect.
The vote is a major victory for the drug’s owner, North Carolina-based Sprout Pharmaceuticals. Two previous attempts to win approval of flibanserin before the same FDA committee failed amid questions about the drug’s risks and efficacy. Though a final decision will be made in the com--
ing months by FDA Commissioner Stephen Ostroff, the panel’s recommendation is likely to weigh heavily.
“I think it’s a major step forward in better understanding of women’s sexuality and better understanding of women being able to take control of their own sexuality in a healthy way,” said National Organization for Women President Terry O’Neill.
The debate over developing and marketing a pill to treat women’s sexual problems has run for years as scientists and pharmaceutical companies rushed to duplicate the success of the blockbuster drug Viagra.
Supporters of flibanserin complained that the FDA has approved several sexual-dysfunction drugs for men, including Viagra, but not a single one for the millions of American women suffering from low libido. Critics accused the agency of a sexist double standard.
Opponents of the drug argue that pharmaceutical companies are seeking to profit by medicalizing what they say is often an emotional or relationship issue.
“We keep getting this narrative from the drug company and the patients that these women are unfixable without the drug,” said Thea Cacchioni, a women’s stud-
‘I think it’s a major step forward in … better understanding of women being able to take control of their own sexuality in a healthy way.’
— Terry O’Neill,
ies professor at the University of Victoria in Canada, adding that research suggests non-pharmaceutical solutions could address some of the same issues.
If ultimately approved, flibanserin would be the first nonhormonal treatment for “hypoactive sexual desire disorder,” or HSDD, in premenopausal women. The condition aff licts some 4.8 million premenopausal women, but physicians have had essentially nothing to offer them, according to Sprout.
While Viagra and similar drugs work by increasing blood flow to create an erection, f libanserin works on key chemicals in the brain to stimulate a woman’s sexual desire.
Critics are still urging the FDA to reject the drug, citing its side effects and lackluster results.
Chief among the safety concerns is evidence from clinical trials showing that some women taking flibanserin are at higher risk of low blood pressure and fainting. Members of the panel were particularly concerned about the risk when flibanserin is taken with alcohol.
Although members of the panel suggested a litany of additional safety precautions to accompany the drug, the final decision lies with the FDA.
In clinical trials, flibanserin was found to somewhat increase the number of “sexually satisfying events” women reported to researchers. On average, women taking the drug reported up to one more such event per month, compared with women taking a placebo.
At a hearing Thursday, supporters — including doctors and clinical trial participants — defended the drug, saying even small improvements were important to patients.
A couple of years after she got remarried, Amanda Parrish, 52, of Brentwood, Tenn., noticed she no longer initiated sexual contact with her husband, Ben. “A wall went up between us,” she said in an interview.
About a year later, she found an HSDD pamphlet in her doctor’s office and joined the flibanserin trial.
“I personally was elated that there was a legitimate medical reason for what was going on,” she said. After taking the drug, her relationship quickly improved, she said. But since the trial ended, she said, the condition has returned, causing stress and anxiety.
She said she left the Thursday vote elated. “I actually said to them as we left today, ‘Can we all get some to take home tonight?’ ”
Sally Greenberg, execu- tive director of the National Consumers League, said she supported approval because without an FDA-certified drug, women might turn to unregulated or dangerous substitutes. “There is a huge unmet need for women’s low libido,” Greenberg said before the vote.
The FDA faced a strong public campaign, partly organized by Sprout, in support of drug, including websites such as EvenTheScore.org and WomenDeserve.org, characterizing the debate as one of gender equality and fairness.
“If you vote no today based on this risk, it would signal that you do not believe that HSDD warrants treatment at all,” said Anita Clayton, a University of Virginia professor who has worked as consultant for Sprout but said she had no financial stake in the drug. “Maybe the message is that you do not trust women with HSDD not to drink to intoxication, or you just don’t trust women.”
The drug was developed by German pharmaceutical company Boehringer Ingelheim, which first asked the FDA in 2010 to consider approval. An advisory panel voted 10 to 1 to recommend against it, citing scant evidence of the drug’s effectiveness. Sprout Pharmaceuticals later acquired the drug from Boehringer.
FLIBANSERIN, a 100-milligram pill taken daily at bedtime, had a small effect in clinical trials. But critics accuse pharmaceutical companies of seeking to profit by medicalizing what they say is an emotional issue.