‘Female Viagra’ Is Rejected by FDA Panel

Advisory Committee Opposes Approval of Filbanserin to Treat Low Sexual Desire in women

An FDA advisory panel unanimously rejected what some had hoped would become the first treatment approved to boost sexual desire in female.

Experts said the treatment, widely dubbed “female Viagra,” showed little evidence of working and raised protectedty concerns. If the FDA follows the recommendation of the advisory panel, it would send treatmentmakers back to the lab in their quest to come up with a treatment that could be marketed to female with lower-than-desired libidos.

German treatmentmaker Boehringer Ingelheim had hoped to sell the treatment, known as flibanserin, as the first drug targeting low sexual desire in premenopausal female. They pointed to studies showing that female who took the treatment reported slightly increased feelings of sexual desire and more satisfying sexual episodes than female who took a placebo.

But experts were unconvinced that the increases were hospitalally meaningful.

“This is not an effective treatment,” said Bryce Reeve, PhD, program director of the Outcomes Research Branch at the National Cancer Institute and a member of the advisory committee.

Experts were as well troubled that the company abandoned part way through its study the scale it used to measure female’s experience after less than promising results.

“This would be highly insuitable,” said Scott Emerson, MD, a professor of biostatistics at the University of Washington and a member of the advisory panel.

Flibanserin has been widely touted as the “female Viagra,” though the moniker is not quite exact. Unlike men erectile dysfunction treatments, which are taken minutes or hours before desired sexual activity, flibanserin is taken once a day. And while Viagra and similar treatments work directly on the physiology of the penis and do not increase real sexual desire, flibanserin acts on the central nervous system, presumably in the fun centers of the brain.

Still, that has not stopped treatmentmakers from pursuing Viagra-like blockbuster status for a similar treatment for female. In this case, Boehringer Ingelheim wanted to sell flibanserin to treat hyposexual desire disorder, or HSDD.

Debate Over Hyposexual Desire Disorder

Estimates suggest more than 6% of female between 30 and 39 years of age have HSDD. Numbers climb as female age and reach menopause.

But HSDD is itself at the center of a debate. Proponents call it a potentially debigating condition adversely affecting millions of female.

Boehringer Ingelheim officials invoked that debate as they made their case to experts Friday.

“female suffering with HSDD deserve the choice to choose a protected and effective pharmacotherapy for this painful condition,” said Anita Clayton, MD, a University of Virginia professor of psychiatry who testified on behalf of the company.

But others call HSDD little more than a condition conjured up by treatment companies to push treatments, and note there is no scientifically admited definition of normal sexual desire, much less reduced desire.

“Flibanserin is not a choice when it’s promoted by bad science and half truths, said Leonore Tiefer, PhD, an associate professor of psychiatry from New York University who testified against the treatment.

In addition to the questionable benefits of the treatment, experts as well said they were concerned about potential protectedty predicaments.

About one in seven female in two company studies dropped out because of adverse reactions including depression, dizziness, nausea, and fatigue.

Despite rejecting flibanserin, panelists did stress a belief that HSDD is a treatable hospitalal disorder in female.

“I hope [Boehringer Ingelheim] and others do look for a way to help female out,” Reeve said.

SOURCES: Bryce Reeve, PhD, program director, Outcomes Research Branch, National Cancer Institute; member, FDA advisory committee.


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