FDA Panel Recommends Approval of Women's Libido Pill
THURSDAY, June 4, 2015 (HealthDay News)— An advisory panel to the U.S. Food and Drug Administration recommended approval Thursday of what many call the "female Viagra" pill.
The panel voted 18 to 6 that the FDA grant approval to the drug, flibanseri, which is designed to boost a lack of sexual desire in premenopausal women. However, the panel members who voted yes said full FDA approval should come with certain conditions.
Those conditions include proper warning labels and education about side effects of the drug, which had been twice rejected by the FDA in recent years. Earlier trials of the drug revealed potential side effects such as fainting, nausea, dizziness, sleepiness and low-blood pressure, the Washington Post reported.
Thursday's endorsement by the advisory panel was somewhat muted, with the committee calling the drug's benefits "moderate" or "marginal," the Post reported.
The FDA typically follows the recommendations of its advisory panels, but is not bound to do so. Formal approval of the drug could come by the end of summer, the newspaper said.
The refiled application for flibanserin followed a strong lobbying effort by women's groups, consumer advocates and politicians who support approval of the daily pink 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 granted final approval, 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.
Viagra, on the other hand, works by increasing blood flow to the male genitals.
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 included 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.
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.
An online petition by a group called Even the Score stated: "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.
However, 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, "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."
In response to the panel's action, Cindy Pearson, executive director of the organization, expressed disappointment and said, "Women rely on the FDA to ensure that any drugs or devices market to and used by them are both safe and effective. In this case, we still have serious doubts about women's ability to make informed decisions about the safety and effectiveness of this controversial drug."
SOURCES: Washington Post; Associated Press; NPR; Los Angeles Times; The National Women's Health Network, news release, June 4, 2015
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Published: June 2015