One of the many concerns the FDA staff had about this drug application—nicknamed the “pink Viagra”—was the way participants reported their responses to the medication or the placebo. Participants were not asked to chart daily. In light of the goal of the drug, to correctly measure study subjects’ change, if any, in sexual responsiveness, it is difficult to assess data based on recall.

The improvements participants reported were described as “underwhelming,” which they were. In light of the side effects—dizziness, nausea and fatigue—the adverse reactions were greater than the reported benefits. This drug would be used over many years were it to be approved.

This New York Times story says that the chairwoman of the FDA advisory panel reviewing the application noted these issues but also encouraged the pharmaceutical company to do more research.

The New York Times

“A federal advisory panel on Friday unanimously voted against recommending approving a drug to treat female sexual desire disorder, but it encouraged the company to continue its research.

“That vote by the panel, an adviser to the Food and Drug Administration, followed an F.D.A. staff report earlier this week that also recommended against approval. Such advisory votes do not always influence the F.D.A.’s final decision on a drug, but often they do.

“The panel, the Reproductive Health Drugs Advisory Committee, voted against a new drug application by Boehringer Ingelheim, a German pharmaceutical company. Dr. Julia V. Johnson, the panel’s chairwoman, said that the drug’s impact was “not robust enough to justify the risks,” which include dizziness, nausea and fatigue, particularly with long-term daily use. (Emphasis added)

“But Dr. Johnson, head of the department of obstetrics and gynecology at the University of Massachusetts Medical School, encouraged Boehringer to perform more research. The drug, originally intended as an antidepressant, was meant to elevate sexual desire in premenopausal women who are distressed by diminished libido.” (Emphasis added)

Source: New York Times, June 18, 2010