‘Female viagra’ fails to win approval from advisory panel

A drug that claimed to treat female sexual desire disorder failed to win approval from a federal advisory panel on Friday.

However, its failure to win votes encouraged the company to continue its research.
 
The panel’s opposition followed an FDA staff report earlier this week that also recommended against approval.

Such advisory votes do not always influence the FDA’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.

But 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 libidos.

Another panel member, Dr Kathleen Hoeger, a reproductive endocrinologist with the University of Rochester Medical Center, said that the research was “incredibly important” but that more work was required to improve long-term safety.

The Boehringer drug, flibanserin, affects brain chemicals, like dopamine and serotonin, thought to be involved with sexual drive.

The FDA staff found that it had effectively increased the number of sexually satisfying events reported by more than 1,000 women with depressed libido, increasing those events by a statistically significant 0.8 per month in randomised, placebo-controlled experiments.

But the staff found the drug had not been proved to increase women’s desire — a crucial element of the diagnosis, which involves low or no sexual interest to the point of distress in otherwise healthy people.

The diagnosis, called hypoactive sexual desire disorder, is itself controversial.

In the last month, Boehringer has mounted a publicity campaign promoting the disorder, in advance of FDA decision-making.

Dr Anita H Clayton, a Boehringer consultant and psychiatry professor at the University of Virginia, said the desire disorder affected 6 to 10 percent of premenopausal women, although that estimate was challenged by several speakers at the advisory committee hearing.

Boehringer will continue its research on the drug, a company official said after the vote.

“We are disappointed with the advisory committee’s recommendations and will work with the FDA to address questions raised,” the New York Times quoted Dr. Christopher Corsico, Boehringer’s United States medical director, as saying in a statement.