June 20, 2010

Drug for Sexual Desire Disorder Opposed by Panel

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.

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 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 F.D.A. 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 randomized, 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 F.D.A. 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 F.D.A. to address questions raised,” Dr. Christopher Corsico, Boehringer’s United States medical director, said in a statement.

Earlier this week, the company said it was also working in other countries to gain approval for the drug. Lara Crissey, a spokeswoman, wrote in an e-mail message, “We are in discussions with various regulatory agencies worldwide.”

The panel’s 11-to-0 vote was the second time in six years that an F.D.A. advisory panel had unanimously opposed a drug maker’s attempt to treat the female sexual dysfunction. There is no approved drug for the condition.

Various hormonal therapies have been tried.

The F.D.A. rejected a proposed testosterone patch from Procter & Gamble in 2004. That product was approved in Europe in 2006 for use by women who suffered low libido after removal of their uterus and ovaries, after all other forms of sex therapy failed. The product, Intrinsa, has been widely used by women in England who are not surgically menopausal.

BioSante Pharmaceuticals of Illinois plans to seek F.D.A. approval next year for a testosterone product called LibiGel, its spokesman, Alan Zachary, said Friday.

Some doctors already prescribe hormone therapies in so-called off-label uses. Over 4 million testosterone prescriptions were written for women’s sexual dysfunctions in 2009, although it has not been approved by the F.D.A. for that, said Stephen M. Simes, BioSante’s president.

Sheryl A. Kingsberg, a psychologist, Case Western Reserve University medical professor and prominent industry consultant, said widespread off-label use of hormonal drugs indicated a pent-up demand for pharmaceutical help for women.

Professor Kingsberg said Friday that she was disappointed in the F.D.A. advisory vote because Boehringer’s product would have been the first one on the market for younger women with the sexual desire disorder, treating them without hormones.

“I certainly hope Boehringer doesn’t give up,” she said in a phone interview. “Flibanserin showed an awful lot of promise. I’m going to have some very, very disappointed patients if there’s nothing for them.”

But Amy Allina, program director for the National Women’s Health Network, an advocacy group, said: “For some it may turn out that there is a drug that provides effective treatment. But this drug is not it.”

The above article is reproduced from material entitled 'Drug for Sexual Desire Disorder Opposed by Panel' as provided by The New York Times. Note: Materials may be edited for content and length.

No comments:

Post a Comment

Got something to say? We appreciate your comments: