Pharmaguy's Insights Into Drug Industry News

How do you measure sexual desire?

If you’re a drugmaker trying to win approval for a medication to boost female libido, it might come down to two questions on a medical questionnaire. Those questions made the difference for Sprout Pharmaceuticals, which received federal approval Tuesday for Addyi, the first pill for women who suffer from a loss of sexual appetite.

But the history and development of that questionnaire — funded by drugmakers — underscores how closely the field of sexual medicine is intertwined with the pharmaceutical industry. And lends weight to arguments that low libido is just the latest commonplace sexual problem — like impotence or low testosterone — to be transformed into a medical condition by drugmakers.

Today, the form is widely-used, cited in hundreds of papers on women’s sexual health. But for years it failed to win the support of one critical group of experts: the Food and Drug Administration.

That presented a challenge for Sprout and its drug Addyi, which the FDA rejected twice in 2010 and 2013 due to side effects and minimal benefits. Regulators noted that the original drug studies failed to show an increase in female desire based on daily journal entries by women.

Sprout argued that the FDA should disregard those results and instead look to monthly results from the questionnaire, which showed a small, but statistically significant, boost. Patients taking the drug reported a 34 percent increase in desire, compared with 25 percent for women taking a placebo.

Finally, in its third round reviewing the pill, the FDA conceded that while the form “may not be an optimal assessment, it may provide interpretable findings of efficacy.”