FDA Panel Votes to Approve ‘Female Viagra” Pill Flibanserin
Experts say the Food and Drug Administration should approve a once-a-day pill to treat women who have lost their sex drive, but says the company should take care to make sure women can take it safely.
“I have serious, serious, serious safety concerns,” said Dr. Walid Gellad of the University of Pittsburgh, one of the panel members who voted to recommend approval anyway. “The benefits are modest, maybe less than modest. But I think that puts it in good company with other approved drugs.”
The packed room erupted with applause as the committee voted 18 to 6 to recommend approval of the drug often called “the female Viagra.” But the FDA is still free to approve the drug or not. It’s rejected it twice before.
More than 30 people spoke to a day-long hearing about the drug, which would be the first approved specifically to treat female libido.
The hearing pitted passionate supporters against critics who said while there’s a need for something for women suffering from sexual desire disorders, this pill isn’t it.
“I’m elated,” said Amanda Parrish of Nashville, who testified in favor of the drug’s approval.
“It is probably going to come with great restrictions and stuff, but who cares? If they had turned it down again, it would have been gone forever.”
The advisers says the company needs to address the risks that the drug causes women to faint, and to take special care to warn women not to use it along with alcohol.
“Make no mistake: This pill will be widely used off-label,” said Dr. Adriane Fugh-Berman, a pharmacology professor at Georgetown University who’s spoken out strongly against approval. “There will be an epidemic of adverse events.”
Fugh-Berman said Sprout’s “brilliant marketing strategy” was pressuring FDA.
Cindy Whitehead, president and chief operating officer of Sprout Pharmaceuticals, which has been seeking to market flibanserin, says she’s ready to negotiate with FDA about approval.
Several of the panelists said they’d recommend a Risk Evaluation and Mitigation Strategy, or REMS, program. FDA can mandate such a plan, which goes beyond written warnings in a product label or insert.
“We did already have a proposed REMS program,” Whitehead told NBC News.
She added that the company has also proposed a post-marketing study to keep an eye out for side effects once a product is being used outside the careful constraints of a clinical trial.
“We are anxious to get into dialogue with the agency about those things,” she said.
Whitehead said the vote vindicates the dozens of people who spoke in favor of the drug, including several women — and their husbands — who overcame embarrassment and traveled on Sprout’s tab to speak publicly about their sexual struggles.
“My marriage has suffered greatly,” said Vicki Lofthus of San Diego “Divorce is on the table.” Lofthus’s parents, Barbara and Gregg Gattuso, also pleaded for approval. Sprout paid for them to come to the hearing, held at FDA’s headquarters in Silver Spring, Maryland.
“Based on the comments from the panel, they really did hear their suffering, hear their distress,” Whitehead said.
08 – June – 2015