October 31, 2014 — Testimony from experts and advocates at a two-day FDA workshop on issues related to the lack of sexual dysfunction drugs left several unanswered questions for the agency as it considers developing guidance for such drugs, MedPage Today's "The Gupta Guide" reports (Gever, "The Gupta Guide," MedPage Today, 10/29).
On the first day of the workshop, several women called on the agency to do more to encourage drugmakers to develop treatments for female sexual dysfunction -- sometimes called hypoactive sexual desire disorder -- while some experts questioned whether a drug is appropriate or even possible to address such issues (Women's Health Policy Report, 10/28).
In addition, some speakers pointed out that many of the speakers urging FDA to take further action were indirectly compensated by Sprout Pharmaceuticals, which is attempting to gain FDA approval for its sexual dysfunction drug. The agency has asked the drugmaker to conduct further clinical trials. FDA previously rejected the drug, but Sprout submitted a new application.
The second day of FDA's workshop, on Tuesday, focused on scientific questions regarding how FDA would evaluate drugs to treat sexual dysfunction in women. The workshop featured a panel of academic and clinical experts specializing in sexual medicine and psychiatry, as well as speakers from academia.
A central issue in Tuesday's discussion was that the current Diagnostic and Statistical Manual of Mental Disorders, or DSM-V, includes a definition of "female sexual interest/arousal disorder" that combines what some experts considered two potentially separate clinical issues: a lack of sexual interest and a lack of sexual arousal. As a result, the experts said it would be difficult to design clinical trials to evaluate drugs to treat FSIAD because some drugs might only treat one of the two issues.
In addition, the experts debated how often women would need to complete questionnaires to evaluate their FSIAD symptoms during potential clinical trials. Several panelists suggested that FDA's typical approach of having participants in such trials complete daily diaries might be overly burdensome and urged an alternative approach ("The Gupta Guide," MedPage Today, 10/29).