Female libido drug won’t be marketed on TV

Sprout Pharmaceuticals gained approval for the drug flibanserin on Tuesday from the Food and Drug Administration. It will be sold commercially as Addyi, and it’s the first product devoted to treating female sexual dysfunction.

Drugs treating sexual dysfunction in men have gotten heat for being too racy, and at least initially, Sprout intends to avoid TV ads altogether. Instead, the company intends to educate the marketplace and doctors about the controversial treatment rather than doing direct-to-consumer advertising and marketing, CEO Cindy Whitehead told reporters on a conference call.

Whitehead did not rule out direct-to-consumer advertising in the future, but said it’s more important now to set up the certification program mandated by the FDA for the treatment. To dispense Addyi, a pharmacist must go through a certification program online.

TV ads for male sexual dysfunction have been controversial at times for drug makers. A 2009 House bill sought to restrict such ads to late evening hours, and not during the day when children might be watching.

Whitehead noted that the drug is very different from the male treatment it is mainly compared to, Viagra. Addyi is taken every day and impacts chemicals in the brain to help improve sexual desire. Viagra, on the other hand, is taken only before sex.

Addyi works similar to an antidepressant, where you have to take it for a few weeks to even a month or two to get the effect, said Anita Clayton, a professor at the University of Virginia who led the clinical trial of approximately 11,000 women.

The agency approved the drug after a coordinated lobbying campaign accused regulators of gender bias, since before its approval, there were no treatments for women for sexual dysfunction.

Addyi, which was rejected twice before by the FDA, was approved with several caveats to ensure patient safety such as the pharmacy certification. The drug has an increased risk of high blood pressure and cannot be taken with alcohol.