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What's the Real Deal with Female Viagra? 2015-06-03
By Alex Ronan

The less-than sexily named flibanserin, sometimes called the “female version of Viagra,” may finally get FDA approval this week. The pill, which targets lost libido in women, has been twice rejected.

Creating a “female version of Viagra” is way harder than it might seem. Viagra works on the arteries, causing physical shifts that result in erection. Historically, disorders of women’s sexual desire haven’t responded to drugs that act on hormones or blood flow; unlike Viagra, a female-desire drug would need to make adjustments in the primal and executive regions in the brain, tapping into the psyche.

Flibanserin was first rejected in 2010. When weighed against several side effects like nausea, dizziness, and sleepiness, its limited effectiveness wasn’t enough to secure approval. A committee of outside advisers unanimously advised against approval. Two years later, the FDA again rejected the drug for showing only “modest” benefits.

Proponents of the drug have suggested a lack of approval reveals gender bias; opponents suggest issues surrounding female libido are too complicated to be solved by a single pill.

When Sprout Pharmaceuticals bought flibanserin after its second rejection, the company launched a multi-pronged effort to secure approval. Sprout appealed the 2012 ruling, even though such efforts "often go nowhere," according to The Wall Street Journal’s Pharmalot blog. Sprout spun the rejection as a gender-bias issue, which quickly caught the attention of media and lawmakers.

In January of 2014, four female lawmakers criticized the FDA for failing to approve any drugs that address female sexual dysfunction. “There are 24 approved medical treatments for male sexual dysfunctions and not one single treatment yet approved for the most common form of female sexual dysfunction,” Representatives Debbie Wasserman Schultz, Chellie Pingree, Nita Lowey, and Louise Slaughter wrote in an open letter to the FDA. Critics have called this number an overstatement, saying that it’s artificially inflated with the inclusion of generics and slight variations.

Sprout backed a media campaign called “Even the Score,” which has also garnered support from a number of nonprofits and consumer advocacy groups in addition to other companies working on drugs to treat female sexual dysfunction, like Palatin Technologies and Trimel Pharmaceuticals.

While positioned as something of a grassroots crusade against gender discrimination in sexual-dysfunction drug approvals (the site encourages visitors to "join the movement" and "share your story"), the site was purchased by Blue Engine Message and Media, a company that “frequently collaborate[s] with corporate communications, marketing and government relations teams to implement priority programs when reputation, brand or market position face a threat or opportunity.” Over the phone, Blue Engine declined to comment on who exactly is at the forefront of the campaign. Via email, Blue Engine told the Cut that Even the Score is supported by its members and that they “do not provide breakdowns regarding individual contributions to the campaign.”

Responding to the campaign, media pressure, and increased interest of lawmakers, the FDA met with eight women’s groups last spring and hosted a summer workshop to develop ideas for drugs that might effectively counteract female sexual dysfunction.

Not everyone buys the gender-bias story; regarding the ongoing conversations about flibasnerin, a number of women’s health advocates, health-care providers, scientists, and researchers sent a letter to Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research.

It is not only reasonable, but vitally important for organizations advocating on behalf of women’s health to press on all fronts for women to have both the information and the resources needed to achieve satisfactory sexual lives. However, women also rely on the FDA to ensure that any drugs or devices that we use for this purpose are both safe and effective. The problem with flibanserin is not gender bias at the FDA but the drug itself.
Unlike male sexual enhancement drugs, which are taken on an as-needed basis, flibanserin requires daily, long-term use and impacts the central nervous system and levels of dopamine and adrenaline in the brain.  The group called for more rigorous, long-term testing.

The FDA has given Sprout suggestions for securing approval: running short-term studies testing flibanserin for signs of driver impairment as well as the effects of its interaction with other drugs. Sprout hopes the drug will get approval and join Viagra on the market this summer.

Patent Pending:   60/481641
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