The pink pill: Viagra for the female brain

“After my first son was born, I noticed it right away. It was there one day, gone the next,” says Campbell. The married mother of two says she suffers from hypoactive sexual desire disorder, a condition characterized by chronic low libido in women.

Experts in the field say it’s related to brain function. “We know there is this area of the limbic system that is associated with the neurotransmitters dopamine and norepinephrine that is functioning differently in the women with HSDD,” says Leah Millheiser, director of the Female Sexual Medicine Program at Stanford School of Medicine.

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A company called Sprout Pharmaceuticals has been lobbying the Food and Drug Administration to approve its experimental drug, which would be the first treatment of its kind for this problem. “Flibanserin is a novel, non-hormonal pill to treat hypoactive sexual desire disorder in premenopausal women,” says Sprout CEO Cindy Whitehead.

Critics say the so-called “little pink pill” has not proven to be safe or effective. “This is a drug that’s meant to be taken every day for the rest of a woman’s life. We don’t know what the long-term effects are,” says Adriane Fugh-Berman, associate professor at Georgetown University Medical Center and director of the research project PharmedOut.

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She also questions the validity of HSDD as a diagnosis. “Low desire is not a medical condition, and in fact the term hypoactive sexual desire disorder has been eliminated from the latest ‘Diagnostic [and] Statistical Manual,’” Fugh-Berman says.

“Low libido can be caused by a number of different things, including diabetes, depression, other medical conditions, medications — particularly antidepressants and relationship problems.”

The FDA balked in 2013 when Sprout resubmitted a new drug application for flibanserin, which had been rejected once before, while it was held by the German pharmaceutical company Boehringer Ingelheim, citing side effects such as sleepiness and nausea. It also refuted claims that the decision was in any way sexist.

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“We do not believe there has been any gender bias with regard to our review of this drug,” the agency said in a statement. “We engaged in a scientific process in which we evaluated whether the drug’s benefits outweigh its risk.”

Sprout appealed and has just announced it is once again resubmitting flibanserin for FDA approval. The application could take up to six months to review.

If approved, flibanserin could be a huge windfall for Sprout.

The current erectile dysfunction treatment market is $5B USD globally. 1 in 10 women suffer from HSDD, the same number as men with Erectile Dysfunction.

Campbell hopes this time around the FDA gives their stamp of approval. "If men have an issue, by all means get treatment for it. I just want to be able to have the same options for myself.”