FDA Panel Weighing Women's Libido Pill

Vote expected Thursday after agency twice has rejected the sexual dysfunction daily medication

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By HealthDay staff

HealthDay Reporter

THURSDAY, June 4, 2015 (HealthDay News) -- A drug meant to boost women's sexual desire is being considered for approval Thursday by an expert panel from the U.S. Food and Drug Administration, after being rejected by the agency twice in recent years.

The refiled application for the drug flibanserin follows a strong lobbying effort by women's groups, consumer advocates and politicians who support approval of the daily pill for sexual dysfunction, the Associated Press reported. There is no drug on the market for women with low libido, and drug companies have been trying to get one approved since Viagra's successful introduction for men in the late 1990s.

In a statement before the panel convened Thursday, Cindy Whitehead, CEO of flibanserin maker Sprout Pharmaceuticals, said, "The review of flibanserin ... represents a critical milestone for the millions of American women and couples who live with the distress of this life-impacting condition without a single approved medical treatment today," according to an NPR report.

Flibanserin, which would be sold under the brand name Addyi if approved, shifts the balance of the brain chemicals dopamine, norepinephrine and serotonin to treat what is called "hypoactive sexual desire disorder," or HSDD, in premenopausal women.

In clinical trials conducted by Sprout, women whose average age was 36 took the medication for five months and reported an increased sexual desire, reduced distress and an increase in "sexually satisfying events" compared with women taking a placebo, the Los Angeles Times reported.

The latest application by Sprout includes new information requested by the FDA about how the pill affects driving ability. FDA scientists asked for the data because previous results in company clinical trials found that sleepiness occurred in nearly 10 percent of women who took the drug.

In the new study, Sprout compared the driving ability of women the morning after they took flibanserin with those who took a common sleeping pill or a placebo, the AP reported.

The FDA refused to approve flibanserin in 2010 and again in 2013, citing low levels of effectiveness and such side effects as nausea, dizziness and fatigue, the AP reported.

In an effort to pressure the FDA, groups funded by Sprout and other drug companies began pushing the lack of a female libido drug as a women's rights issue.

For example, an online petition by a group called Even the Score states: "Women deserve equal treatment when it comes to sex," and has collected nearly 25,000 supporters.

The group receives funding from Sprout Pharmaceuticals, Palatin Technologies and Trimel Pharmaceuticals, all of which are working on drugs to treat female sexual disorders. Nonprofit supporters of the group include the Women's Health Foundation and the Institute for Sexual Medicines, the AP reported.

Sprout also sought support from politicians, and four members of Congress sent a letter to the FDA urging the agency to reassess the drug.

"There are 24 approved medical treatments for male sexual dysfunction and not one single treatment yet approved for the most common form of female sexual dysfunction," states the letter, signed by Rep. Debbie Wasserman Schultz, D-Florida; Rep. Louise Slaughter, D-New York, and two other Democratic congresswomen, according to the AP report.

However, on Wednesday, the National Women's Health Network, a nonprofit advocacy organization, called on the FDA to deny approval of the drug in an organization news release, saying "significant known and unknown adverse reactions, drug-drug interactions and side effects outweigh the drug's benefits."

Cindy Pearson, executive director of the organization, said inattention to women's health may have slowed progress toward finding a drug to address some female sexual problems.

But, she added in the news release, "based on our review of the data about flibanserin, it's clear the problem with this drug is not gender bias at the FDA but rather the drug itself."

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SOURCES: Associated Press; NPR; The Los Angeles Times; The National Women's Health Network, news release, June 3, 2015
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