WASHINGTON — Half of one satisfying sexual encounter a month. That is the average benefit a woman gets when she takes the new female libido drug, sometimes called the “female Viagra,” researchers reported Monday.
Last year the Food and Drug Administration approved the drug, flibanserin, making it the first drug available to treat low sexual desire in women. It was promoted by a group of women’s rights activists who argued it was unfair that men had numerous drugs to boost sexual function while women had nothing.
But public health groups and some other women’s groups contended that the science did not justify its approval. The drug’s effects were modest, they said, and not worth side effects such as sleepiness, dizziness, fatigue and nausea. And the risk of some side effects increased with alcohol consumption.
In the new study, published in JAMA Internal Medicine, researchers found benefits that were slightly more modest than those submitted to the F.D.A. during the approval process. The researchers analyzed eight studies of about 5,900 women, using a method that involved pooling the data. They concluded that treatment with flibanserin, now marketed as Addyi, resulted in “one-half of an additional sexually satisfying encounter per month.” (The study did not define what “one-half” of a sexually satisfying encounter was.)
That result was not very different from original findings of three clinical trials submitted to the F.D.A. as support for the drug’s approval. Those trials found that once women started taking the drug, they had an average of about one additional satisfying sexual encounter a month, on top of the two to three they were having already. That result lifted the benefits above the bar of being scientifically meaningful, but barely. Still, it was enough for the agency’s approval.
In a statement, Dr. Tage Ramakrishna, the chief medical officer at Valeant, the company that now owns the drug, said that the new analysis confirmed the findings of the clinical trials and “provided little additional context.” He said the way the analysis was done, combining data from a number of different studies, carried “less statistical weight” than the randomized trials .
The drug was approved last June, after twice being rejected by the agency over several years. In the clinical trial results submitted, women taking the drug also reported on monthly questionnaires that they felt more desire, although the difference compared with a placebo was also meager — only about 0.3 points on a scale ranging from 1.2 to 6.0.
Experts who had opposed the drug’s approval said the JAMA analysis, which confirmed that the drug increased the risk of dizziness, sleepiness, nausea and fatigue, underscored the meagerness of the benefit.
“An additional half a satisfying sexual encounter a month — is that meaningful?” asked Dr. Adriane Fugh-Berman, the director of PharmedOut, a project at Georgetown University that questions the influence of drug companies on the practice of medicine. “I think only the women can answer that, but perhaps they already have with their lack of enthusiasm for getting prescriptions.”
The drug is not selling well. As of early January, Addyi was generating only 240 to 290 prescriptions a week, according to a report last week by David Maris, an analyst at Wells Fargo Securities, who cited the prescription tracker IMS Health as the source of the data. Mr. Maris estimated that sales of Addyi were running at a rate of $11 million a year, well below the $100 million to $150 million in sales that Valeant said it hoped to achieve this year.
Still, some said the drug helped. Dr. Lauren Streicher, an associate clinical professor of obstetrics and gynecology at the Feinberg School of Medicine at Northwestern Memorial Hospital in Chicago, said a number of her patients have taken the drug and reported significant increases in libido. None has discontinued use because of side effects, she said.
The analysis was undertaken by researchers in Europe, but one of the study’s authors, Dr. Ellen Laan, an associate professor in the Department of Sexology and Psychosomatic Obstetrics and Gynecology at the Academic Medical Center at the University of Amsterdam, has been an opponent of the drug. Last year, she helped organize a letter to the F.D.A. opposing the approval and signed another letter to Congress that said the argument about gender equality was “misleading and dangerous.”
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