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FDA OK means changes for Raleigh drug firm, doctors' talks with female patients

Posted August 19, 2015

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— Sprout Pharmaceuticals' little pink pill hasn't even hit pharmacy shelves, but it's already having an effect on the Raleigh company and on women's relationships with their physicians.

The U.S. Food & Drug Administration on Tuesday approved Sprout's drug Addyi, marking the first time the government gave its OK for a drug to treat sexual dysfunction in women.

Sprout officials said Wednesday that they plan to ramp up their sales force to 200 people in the coming weeks in advance of Addyi's October launch. The company now employs 34 people overall.

"I am so excited about this approval," said Katherine Campbell, who testified before the FDA about her struggle with hypoactive sexual desire disorder and her frustration to get answers from her doctor. "I started looking around on Internet, which is what most normal people do, trying to self-diagnose."

Addyi, which goes by the generic name flibanserin, works by targeting the brain -- to increase a woman's libido.

Dr. John Thorp, a professor in the Department of Obstetrics & Gynecology at the University of North Carolina School of Medicine, was involved in early research trials of Addyi and is critical of the drug.

"Its biologic effects look modest to me, at best," Thorp said.

The FDA previously rejected Addyi two times for lackluster results and safety concerns. The drug can cause a drop in blood pressure and loss of consciousness, especially when mixed with alcohol.

The government is requiring Sprout to include warnings on Addyi packaging and doctors and pharmacists to certify that they have undergone training on counseling patients about the risks before they will be allowed to prescribe and dispense the drug.

Still, Thorp supports the conversation Addyi has created about "the power of sex and the power of women."

Addyi will have a dramatic impact on women, he said, whether they actually take the drug or simply use the momentum to get help for an issue from which many would rather hide.

"It is a common problem in women in their late 30s early 40s," he said. "I think it'd be worth a trial as part of the conversation."

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