Moms Columns & Blogs

FDA has doubts on ‘female Viagra’

By Matthew PerroneAssociated Press

WASHINGTON The first pill designed to boost the female sex drive failed to make a significant impact on libido in two studies, federal health regulators said, though some women did report slightly more sexually satisfying experiences.

The Food and Drug Administration is considering Boehringer Ingelheim’s drug flibanserin for premenopausal women who report a lack of sexual desire, a market that drugmakers have been targeting for more than a decade, since the blockbuster success of Viagra for men.

The search for so-called “female Viagra” has proved elusive though, with many drugs abandoned after showing lackluster results.On Friday the FDA will ask a panel of experts to weigh in on the safety and effectiveness of Boehringer’s drug. The agency is not required to follow the group’s advice, though it often does.

In its review posted online Wednesday, the FDA said two Boehringer studies failed to show a significant increase in sexual desire, as recorded by women in a daily journal. Women taking the drug reported slightly more sexually satisfying experiences, but the FDA said that was not the study’s primary measure.

“The division wanted to see that an effect of treatment is an overall increase in sexual desire regardless of whether a sexual event occurred or not,” states the FDA review.

The FDA also noted increased side effects like depression, fainting and dizziness seen among women taking the pink pill.

The drug, which is related to the antidepressant family, affects serotonin and several other brain chemicals, though it’s not clear how that increases sex drive.

“We don’t know specifically what the exact mechanism of action is but we believe it acts on brain chemicals that have a role in human sexual response,” said Dr. Peter Piliero, executive director for Boehringer’s U.S. medical affairs.

Since the launch of Viagra in 1998, more than two dozen experimental therapies have been studied for so-called “female sexual dysfunction,” a market that some analysts estimate at $2 billion.

Pharmaceutical approaches to boosting female sexual libido have evolved over time.

Initially, most treatments aimed to increase blood flow to the genitals, similar to Viagra. A second wave of would-be blockbusters focused on boosting hormones, including testosterone, which is linked to sexual interest.

Flibanserin is the first drug to approach the problem through brain chemistry. Experts: It’s too complicated for a pill

Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York, says arousal in women is so complicated that it may be unrealistic to expect a pill to completely address sexual problems.

“In women, there’s no mechanical concern (unlike in men’s sexual dysfunction), so if she’s not having a successful sex life, where is the problem?” Kavaler said.

Leonore Tiefer, a psychiatry professor at New York University who runs a private sex therapy practice, believes drugmakers have oversimplified female sexuality. She says in most cases lack of sex drive has more to do with the quality of one’s relationship and lifestyle than brain chemicals.

  Comments