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As FDA approves 'pink Viagra' for women, controversy persists

As FDA approves 'pink Viagra' for women, controversy persists
flibanserin, will be sold under the brand name Addyi, also known as "pink Viagra." The drugmaker expects it will be available beginning in mid-October. (Allen G. Breed / Associated Press)

After clearing the way for Viagra and more than two dozen other treatments to enhance the sex lives of men, the U.S. Food and Drug Administration on Tuesday gave its blessing to the first medication designed to increase sexual desire in women.

The FDA's approval of flibanserin, often known by the nickname "pink Viagra," reverses two earlier rejections of the pill as a treatment for hypoactive sexual desire disorder, or HSDD. The decision follows a public campaign challenging the agency to close a widening gap between the number of drugs available for men's sexual health and those available to women.

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The approval of flibanserin, which will be marketed as Addyi, offers women distressed by their low sex drive a once-a-day salmon-colored pill. Clinical trials presented to the FDA showed that compared with pre-menopausal women who got a placebo, those who took flibanserin reported a modest but measurable rise in sexual desire and increased their number of "sexually satisfying encounters" by roughly one per month, from a median of two to three to between 2 1/2 and four.

In tests, the most common side effects of the drug included dizziness, sleepiness, nausea and fatigue. Addyi should be taken at bedtime to reduce these risks, the FDA said.

Researchers estimate that about 8.3% of women between 30 and 70 in the United States suffer distress from lack of sexual desire. The condition, only recently deemed a medical disorder, appears to peak between the ages of 40 and 60.

Though many of those women may seek prescriptions for Addyi, the FDA said the drug could be marketed as safe and effective only for patients who had not yet reached menopause. For most women, that happens when they are in their late 40s or early 50s. However, once a drug wins FDA approval, doctors are free to prescribe it to patients as they see fit.

Addyi acts to increase the activity of the neurochemical serotonin in the brain. It was initially developed as an antidepressant, then abandoned by the German drug company Boehringer Ingelheim for lack of effectiveness. The mechanism by which the drug improves female sexual desire — a hugely complex confluence of hormones, mood, circumstance and physiology — is not known.

Sprout Pharmaceuticals, which bought the rights to flibanserin in 2011, said it planned to make Addyi available to patients starting in mid-October. Gynecologists are expected to be the main prescribers, but it could also by offered by primary care physicians and mental health professionals who specialize in sexual health.

Cindy Whitehead, chief executive of the Raleigh, N.C., company, said Addyi would be priced so that women with insurance coverage could get a one-month supply with a copayment of between $30 and $75 per month. That would make the drug as financially accessible to women as most erectile dysfunction drugs are to men, she said.

Sprout's bid to get flibanserin approved on its third try has stirred controversy and debate among doctors, feminist groups, consumer advocates and researchers specializing in female sexuality.

A campaign called "Even the Score" has charged that gender bias at the FDA has left women with sexual problems stranded, while 26 products for men have been waved through the approval process since Viagra was approved in 1998. The lobbying campaign was launched and largely funded by Sprout but joined by many women's health advocates and consumer groups who got members of Congress to send the FDA letters in support of the drug.

Among Addyi's supporters was Amanda Parrish, a 52-year-old resident of Brentwood, Tenn., who tested the drug in an early clinical trial. She said it was "patronizing" to deny women the right to decide what risks they would be willing to take to restore their sex drive.

"We live in a huge double-standard world, and I do think the FDA has set a different standard for women," Parrish said.

Dr. Maureen Whelihan, a Florida gynecologist who specializes in treating women with low libido, said the FDA's action was important because it recognized the need for drugs designed for women.

"This opens a big door to research on women's sexual dysfunction coming down the pike," she said.

Until now, doctors have had few options beyond recommending counseling, psychotherapy and the off-label use of testosterone and estrogen therapy.

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In clinical trials, as many as half of women taking Addyi failed to respond to the medication. But for those who do, Whelihan said, even one additional satisfying sexual encounter a month can be "hugely impactful because, like many things, once you have more of something you like, you want more."

But others complained that all the lobbying had the potential to overshadow concerns about the drug's safety. Dr. Adriane Fugh-Berman, director of Georgetown University's pharmaceutical watchdog project PharmedOut, told an FDA advisory panel in June that "to approve this drug will set the worst kind of precedent — that companies that spend enough money can force the FDA to approve useless or dangerous drugs." The panel voted 18 to 6 to recommend the drug.

Last month, three members of that advisory panel fretted in the pages of the Journal of the American Medical Assn. that the agency was forced to adjudicate questions about Addyi's safety and effectiveness in a "politically charged atmosphere."

The FDA acknowledged it had lingering questions about Addyi's safety. Concern has largely centered on its potential for inducing dizziness, lightheadedness or fainting caused by a sudden drop in blood pressure. That danger appears greatest when those taking the drug are heavy consumers of alcohol, or take CYP3A4 inhibitors, a class of drugs that includes certain antifungal medications, antibiotics, HIV drugs and blood pressure medications.

"Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified healthcare professionals and certified pharmacies," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment."

The FDA will require a boxed warning to highlight the risks.

At the same time, Woodcock sought to counter charges of gender bias in the drug approval process.

"The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction," she said in announcing the agency's decision.

Parrish said she was eager to get back on a drug that "truly did restore my interest in sex. I wanted to get on the rooftop and shout about it."

While she is healthy and has an excellent relationship with her husband, Parrish said her libido, briefly reawakened by Addyi, has since gone to ground. She said she hoped to return to the medication soon, with similar results.

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