NATIONALLY RECOGNIZED SEXUAL MEDICINE EXPERT IRWIN GOLDSTEIN COMMENTS ON FLIBANSERIN APPROVAL

NATIONALLY RECOGNIZED SEXUAL MEDICINE EXPERT IRWIN GOLDSTEIN COMMENTS ON FLIBANSERIN APPROVAL

08-18-2015

Although there are 26 drugs approved to treat male sexual dysfunction, there are no drugs specifically approved to increase women’s libido. The FDA today approved the first drug, flibanserin—nicknamed “female Viagra."

Flibanserin treats female symptoms differently than erectile dysfunction drugs treat men. Viagra and other similar medications target blood flow to the penis. Flibanserin treats low libido in women by targeting the brain to increase desire and decrease inhibition of desire in women.

“Women should have access to medications to improve sexual function, just like men do,” said Dr. Irwin Goldstein, who participated in the development of Viagra. He is the editor-in-chief of Sexual Medicine Reviews and medical director of sexual medicine at Alvarado Hospital—the first hospital-based sexual medicine program in the U.S.

While Goldstein has seen substantial progress in men's sexual health, he has not seen the same progress in treatment for women. The FDA advisory panel has twice sent flibanserin for further study before finally recommending approval as a treatment for women with low sexual desire. Advocates expect that the agency will determine the benefits outweigh the side effects, which can include, sleepiness, nausea and dizziness, counteracted by taking the medication at bedtime.

Flibanserin, which acts on serotonin and other brain chemicals, was originally studied as an antidepressant, but then repurposed as a libido pill after women reported higher levels of sexual satisfaction. In a study, women taking flibanserin reported between 0.5 and 1 more sexually satisfying events per month, compared with women taking a placebo. They scored higher on questionnaires measuring desire and lower on measures of stress, and felt that the improvement to their libido was significant to them.

“The modest benefit of this drug is exactly parallel to numerous modest-benefit drugs that have been approved for men,” Dr. Goldstein said. “Except for a drug to treat dyspareunia, or painful sex, there's nothing to help a woman achieve desire, let alone an orgasm. It is interesting to note that the drugs for male sexual dysfunction were approved despite the side effects, which is absolutely unfair to women.”

All this is not lost on a growing number of women’s organizations – including politicians and the National Organization for Women – which are some of the dozens of participants in the “Even the Score” campaign to push for more female libido-enhancing drugs to be studied and approved.

“Our usual patient is someone who is fearful of losing the relationship she has been in for years and nothing would be more beneficial for her than to replace dread of intimacy with desire for it,” he said.

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