Addyi, the first prescription drug to treat low sexual desire in women, won FDA approval yesterday. Though many have dubbed it the “Female Viagra,” Flibanserin—the pink pill sold under the name Addyi—is quite different from its blue counterpart. First off, Viagra treats the penis, relaxing the blood vessels so that an erection can occur. Addyi, on the other hand, works on the brain. It’s meant to change the balance of certain brain neurotransmitters like dopamine and serotonin, and is more closely related to an antidepressant than an ED drug.
The FDA rejected Flibanserin twice—once in 2010 and again in 2013—citing ineffectiveness and a too-high risk for side effects. And even after its approval—after much lobbying from the drug’s maker Sprout and women’s groups like “Even the Score,”—the drug still carries strong warnings, namely of episodes of extreme low blood pressure and syncope (fainting), especially when taken with alcohol.
Kim Wallen, a sex researcher and professor of psychology and behavioral neuroendocrinology at Emory University, is skeptical of the drug’s effectiveness.
“Looking at Flibanserin on its merits, it does not appear to be a very effective drug,” Wallen tells Forbes. “A majority of Flibanserin’s effect appears to be due to a very large placebo effect. Were Sprout to market the placebo they would have a drug as effective as the active compound with no safety concerns. Of course, the FDA won’t approve a placebo, but it is striking how large is the placebo effect. I suspect that this means that many women who take the drug will initially notice a change, but that after 3 months, or 6 months, or a year they will notice that their libido is right back where it started.”
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In clinical trials, between 9% and 14% of women taking the drug responded to it. And these women had on average an increase of 0.5 to 0.7 “sexually satisfying events” per month compared to placebo. That may not sound like much, but another Forbes article points out that even if only 10% of women respond to the drug, of the 16 million women who are thought to have low sexual desire, that would mean that 1.6 million might be helped.
It’s unclear what the exact price of Addyi—which is supposed to be taken every night before bedtime—will be, but it’s been suggested that it would be roughly equivalent on a monthly basis to ED pills. Ten Viagra tablets, a possible monthly allotment, cost about $400.
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Curated Article and Photo Credit from: The New York Times
Relevant Sources: Forbes 8/19/15 and Forbes 8/18/15
