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Will 'pink Viagra' get approved this time?

Will 'pink Viagra' get approved this time?

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It's been five years since excitement over a female or "Pink Viagra" faded when the FDA nixed the drug candidate. Now flibanserin, developed by Boehringer Ingelheim but sold to another company after its FDA rejection, is back before an FDA committee this week that could recommend approval. 

Flibanserin was developed to treat "hypoactive sexual desire disorder" (HSDD). The new "disease" was originally advertised by Boehringer Ingelheim with an aggressive campaign called “Sex Brain Body: Make the Connection” starring TV personality Lisa Rinna. "If There is No Desire to Get Physically Romantic, You Could Be Suffering from HSDD," blared online news articles as the drug was first under consideration.

 Like Viagra, which was meant to be an angina drug until its erectile effects appeared, flibanserin was groomed to be an antidepressant drug until its effect on female sexual desire surfaced. Some trial participants did not want to surrender their unused pills at the end of the study. Volunteers reported the number of "satisfying sexual encounters" they had on the drug increased from 2.7 to 4.5 times a month in pooled data from placebo-controlled Phase III studies in the U.S. and Europe. To participate in trials, women had to be "in a stable, monogamous, heterosexual relationship" for a year, free from depression and parenting, eldercare and income stress (who does that leave?) and "willing to try to have sexual activity" at least once a month.

While the media dubbed flibanserin the "pink Viagra," it did not increase blood flow to the genitalia like the male Viagra drug but increased the desire for sex--at least theoretically. But, despite medical and media excitement about flibanserin and hopes on Wall Street and within the drug industry, the FDA rejected flibanserin in 2010--not for its side effects like dizziness, nausea and sleepiness but because it didn't seem to work.

Flibanserin was first rolled out at the European Society for Sexual Medicine's annual meeting in Lyon, France as an exciting new treatment for libido impaired women. But, to be covered by insurance, women taking flibanserin would have to suffer from HSDD, which is where the controversy starts. HSDD is defined in the current Diagnostic and Statistical Manual of Mental Disorders (DSM) as "the persistent or recurrent lack (or absence) of sexual fantasies or desire for any form of sexual activity" causing "marked distress or interpersonal difficulty." Yet many women with low sexual desire are okay with it and some have real reasons for it like issues with their partner.

"I have long had a problem with the tendency of the healthcare system, aided and abetted by the pharmaceutical industry, to diagnose as a problem a symptom or sign experienced by the majority of people," wrote Ingrid Nygaard, M.D. in a 2008 Obstetrics & Gynecology editorial, adding that the diagnosis might be driven by grants, stock shares and providers' need for income.

Since Margaret Sanger launched the U.S. birth control movement in 1916 and the Pill became available 50 years later, women are supposedly free to be as lustful or aggressive as they want--untethered by pregnancy concerns. Yet pressure to be more sexual (and the very term "hypoactive sexual desire disorder") or less sexual and "ladylike" shows that women's sexuality is still largely defined by men. While some women, their partners, gynecologists and sex researchers welcome the equality of a female libido pill, others remember the pejorative terms "frigid" and "nymphomaniac" from men defining women's sexuality. The danger of drugs like the Pink Viagra, say critics and feminists, is women's libido being pathologized by their partners or society and monetized by the drug industry. 


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Some women are telling the FDA advisory committee members that  flibanserin is an important step toward equality. Unfortunately, they are funded by PR groups working for the drug makers notes the New York Times

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The FDA's workaround for some of these side effects has been that women are asked to take the drug at bedtime and that it will only be available through specially certified health-care professionals and pharmacies who have gone through some training.

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