Company behind 'female Viagra' bought for $1 billion

Less than 48 hours after the U.S. Food and Drug Administration approved the drug Addyi to improve female sexual desire, the company that makes it was acquired for $1 billion. But some experts are raising questions about whether the drug, which was approved by the FDA after two previous rejections, justifies the high price tag.

Valeant Pharmaceuticals International, Canada’s largest drug maker, announced Thursday that it would purchase Sprout Pharmaceuticals, the North Carolina company that developed Addyi. The deal pays Sprout $500 million up front and a share of future profits based on meeting certain milestones.

The pink pill was approved Tuesday by the FDA for use in pre-menopausal women to treat a persistent lack of sexual desire. Addyi has often been referred to as “the female Viagra,” but that's actually a misnomer. Viagra and the two-dozen other FDA-approved drugs that treat male erectile dysfunction act by increasing blood flow to the genitals. Addyi, on the other hand, works in the brain to increase the neurotransmitters dopamine and serotonin, aiming to increase desire.

That makes Addyi — or flibanserin, the generic name of the drug — the first-ever drug for treating low sexual desire for women or men. Up to 10 percent of women experience low sexual desire, and recent studies have shown that more women experience sexual dysfunction than men — 43 percent of women versus 31 percent of men have it in some form, according to research published in the Journal of the American Medical Association.

Last spring, before the meeting of an outside panel that would recommend whether the FDA ought to approve Addyi, a coalition of advocacy groups called Even the Score launched a Change.org petition citing the need for gender equity in terms of sexual dysfunction treatments. The campaign was rooted in feminist arguments that the FDA was prioritizing men’s medical needs, and that message exploded across social media, backed by groups like the National Organization for Women and the American Sexual Health Association.

The lobbying effort, as disclosed on Even The Score's website, was partially backed by Sprout. 

But Dr. Adriane Fugh-Berman, a pharmacology and physiology professor at Georgetown University Medical Center, raises questions about whether the desire for gender parity may be obscuring the drug’s drawbacks. “This company got this drug approved by attacking the FDA on feminist grounds, on saying the FDA was sexist,” she said. “[But] it’s not feminist to demand a lower standard of safety and efficacy for drugs directed at women than at drugs for men.”

The FDA had rejected Addyi twice, in June 2010 and June 2013, citing concerns about whether its effectiveness outweighed considerable side effects. The drug can cause severely low blood pressure and fainting, which are exacerbated when it is combined with alcohol. The FDA will give Addyi a black-box warning to highlight the risks of severe hypertension when it comes to market in October. It will also require prescribing doctors and pharmacies to go through a training program about the drug.

Fugh-Berman, who is also director of PharmedOut, a research group that aims to expose the effects of pharmaceutical marketing, notes that drugs affecting dopamine receptors—those used to treat Parkinson’s disease, for example—often lower inhibitions, but the research on Addyi doesn't necessarily prove that it is working to affect sexual desire.

In trials with 11,000 patients, Addyi showed a small but statistically significant increase in women’s sexual desire in sexually satisfying events as compared to women who took a placebo drug.

Moreover, Fugh-Berman says, the drug may not be very safe for women who are taking other medications. “This drug is as sedating as four drinks.”

Barry Komisaruk, a psychology professor at Rutgers University and author of the book “The Science of Orgasm,” says that it’s unclear whether low sexual desire can even be considered a medical condition. “There isn’t enough scientific knowledge to be able to make an informed decision about what the cause of it is,” he said, adding that he has never seen a drug that was up for FDA approval get so much attention.

Valeant CEO J. Michael Pearson said in a release that “delivering a first-ever treatment for a commonly reported form of female sexual dysfunction gives us the perfect opportunity to establish a new portfolio of important medications that uniquely impact women.”

The company did not respond to requests for comment from Al Jazeera.