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FDA Advisers Consider Flibanserin, Pill Known as ‘Female Viagra’

Female libido drug is en route to FDA approval 2:33

Witness after witness stepped up Thursday to beg the Food and Drug Administration to approve a "little pink pill" that promises to restore sexual desire to women who have lost it.

"My desire for sex has left the building like Elvis's blue suede shoes," Amanda Parrish, a mother of four from Nashville who's been an outspoken supporter of the drug, told a meeting of FDA advisers who are considering approval.

But critics say it's not clear the drug actually fixes the problem, and they say once it's on the market, thousands of women will be taking it every day. The potential side-effects could be numeorus.

The pill, known by its generic name, flibanserin, is commonly called the female Viagra. But unlike Viagra, it works on the brain. Viagra affects blood flow to the genitals.

Parrish says flibanserin helped her when she tried it. "As if a light switch had been turned on, so was I," she said.

There’s been a lot of controversy over flibanserin (pronounced fluh-BAN-ser-in). The FDA has asked for extra studies on the drug and better measures of the problems it’s supposed to fix.

And some experts say there’s no such thing as the medical condition that drugmakers want to market flibanserin for — hypoactive sexual desire disorder, or HSDD.

“Hypoactive sexual desire disorder was actually invented by pharmaceutical companies,” says Dr. Adriane Fugh-Berman of Georgetown University Medical Center.

“They are incredibly bothered and distressed by these changes."

“It was originally invented to sell the testosterone patch. And certainly there are women that have low libido, but that can be caused by many different things, including medications, such as the birth control pill and antidepressants and blood pressure medicines, for example.”

But experts testifying at a meeting outside Washington say it’s a real disorder that greatly distresses some women. They argue that up to 7 percent of women have the condition, which by definition isn't caused by depression or other medical conditions.

“HSDD has been recognized as a medical disorder for almost four decades now,” Sheryl Kingsberg, a clinical psychologist and professor of reproductive biology at Case Western Reserve University School of Medicine, told the meeting.

Kingsberg, a paid consultant to Sprout Pharmaceuticals, the company seeking FDA approval for the drug, says she’s seen many patients with HSDD. “No longer does she initiate sex or feel responsive to sexual advances,” Kingsberg said. “That drive has been gone for a long time — months and, more commonly, years — before she finds her way to my office.”

Female libido drug is en route to FDA approval 2:33

The FDA says the medical condition has to affect daily life. Kingsberg and other experts say their patients are clearly suffering.

“They are incredibly bothered and distressed by these changes,” said Dr. David Portman, an obstetrician and gynecologist at Ohio State University who helped test flibanserin. They only have sex, he said, out of “a sense of obligation.”

Portman says the drug isn’t meant to turn women into raging sex maniacs. “It’s aimed at rebalancing moderation,” he told the meeting.

“We don't want to make women hypersexual."

“We don't want to make women hypersexual,” agreed Dr. James Simon, professor of obstetrics and gynecology at The George Washington University School of Medicine, who also tested the drug.

“We want to try and find the sweet spot, if you will, between increasing their desire for sex, reducing their distress over low desire, increasing the number of sexual events that they have with their partner but not making them hypersexual,” he told NBC News.

Flibanserin works on at least three message-carrying chemicals in the brain called neurotransmitters. They are serotonin, dopamine and norepinephrine, and they affect the brain’s reward center and ability to feel pleasure in a way that researchers admitted to the meeting they don’t fully understand.

Like other drugs such as antidepressants that affect the brain, it can cause sleepiness, fainting and fatigue. The experts told the FDA committee that these issues can be dealt with by taking the pill at bedtime.

The drug has a patchy history. Drugmaker Boehringer Ingelheim originally tried to get it approved and gave up in 2010 after the FDA rejected it twice. Boehringer Ingelheim gave it to Sprout Pharmaceuticals, a company that exists almost exclusively to get flibanserin onto the market.

How can you tell whether a pill to help sexual desire works? The drugmaker is using a scale called the Female Sexual Function Index. Women are asked: “Over the past four weeks, how often did you feel sexual desire or interest?” and answer on a five-point scale ranging from "never" or "always."

New drugs aim to increase female desire

And the trials looked for so-called satisfying sexual events, or SSEs.

Portman said 52 percent of the patients improved when they took flibanserin, compared to 38 percent of those who took a placebo. Several doctors questioned this. Among nearly 4,000 women who took the drug, flibanserin took them from having an average of one satisfying sexual even every 6 weeks ro so to once a month, although this differed from woman to woman.

The consumer group Public Citizen strongly opposes approval. "There is now considerably more evidence that the drug’s risks outweigh its benefits," the group says in a statement.

The committee will vote Thursday afternoon whether to recommend the drug. FDA is asking the experts to decide whether trials involving nearly 4,000 women show the drug actually works as intended, and works safely.

The FDA doesn’t always follow the advice of its committees but usually does.