The FDA rejected the drug twice before today The scant benefit, along with the side effects, may be why the US Food and Drug Administration rejected the drug twice before today. A panel in June recommended putting the pill — then known by its chemical name, flibanserin — on the market with an 18–6 vote, with certain safety warnings. "The unmet need seems to be so strong that even for a drug with rather modest benefit, I think approving the product with strong limitations seems to be the right step at this point," Tobias Gerhard, a drug safety expert and member of the panel, told The New York Times in June.

No new tests were performed since the most recent rejection Addyi was originally developed as an antidepressant but it failed to show efficacy, according to a report in the Journal of the American Medical Association. But some test subjects recorded a higher libido — suggesting a new development path. Addyi is approved for "hypoactive sexual desire," which is described by the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders — the mental health Bible — as a "persistently or recurrently deficient or absent sexual fantasies and desire for sexual activity" that can't be explained by outside factors like another health condition, medication side effects, or severe relationship stress. The FDA considers this an area of unmet medical need.