tl;dr

A later survey of more than 31,000 women reported that the true proportion of women suffering from FSD-which medical and FDA criteria define as not only the lack of sexual desire or satisfaction, but distress about it-is actually closer to 12 percent.

"It's not the easiest indication," admits Carl Spana, president and CEO of Palatin Technologies, a New Jersey-based company developing a therapeutic for FSD. "But we hope the drugs are soon to come."Just one approval would make all the difference, adds Leah Millheiser, director of the Female Sexual Medicine Program at Stanford University School of Medicine.

In January, Clayton and seven different women's groups, including the National Organization for Women and the Society for Women's Health Research, met with the FDA's head of pharmaceuticals, Janet Woodcock, to express concerns over the agency's flibanserin rejection.

"The benefits did not outweigh the risks," they wrote, citing the drug's "Worrisome side effects profile" and "Unknown long-term effects." And in an article published in Slate in April, journalist turned congressional investigator Paul Thacker accused Sprout of engineering and spreading the idea that flibanserin's rejection was due to sexism at the FDA. The FDA "Carefully weighs the risks and benefits of each drug the agency reviews," according to FDA spokesperson Andrea Fischer.

In February this year, the company received a response from the FDA: do three additional Phase 1 studies to test for any driving impairment while taking flibanserin and to assess the drug's effect on two enzyme pathways in the liver to understand potential drug interactions.

If flibanserin is approved, some 13 years after the first study of the drug began, companies hope it will blaze a path for other drugs.

The FDA-required endpoint asks only for numbers of events, so no matter how good the sex or how happy the woman, if there are no large increases in the number of sexual events, a drug may not be judged effective enough by the FDA to warrant approval.