Sprout Pharmaceuticals Awaits FDA Ruling On Female Libido Drug

By John Murawski
The News & Observer (Raleigh, N.C.)

RALEIGH

Sprout Pharmaceuticals is a small drug company with a potentially very big drug — the world’s first pill to boost women’s sex drive.

The Food and Drug Administration is expected to announce Tuesday whether it has approved Sprout’s drug, Addyi, which the company plans to market as the “little pink pill.” The agency has rejected the drug twice in the past five years because of questions about its safety and effectiveness.

Interest in Sprout’s libido pill is expected to run so high that, to curb potential misuse, Sprout has promised the FDA it won’t advertise the drug for 18 months on TV and radio.

The drug agency’s decision will cap an unusual media offensive conducted by advocacy organizations during the past year-and-a-half. After several dozen groups — including the National Organization for Women and National Consumers League — lobbed accusations of gender bias and paternalism against the agency, an FDA advisory panel in June recommended the FDA should reverse course and approve the drug.

Anticipation about the FDA ruling is evident in Sprout’s 10th-floor suite on Six Forks Road where a pink theme is carried out from the pink molded chairs to pink gum balls. Colorful wall boards trace the drug’s chronology from its German origins as an experimental anti-depressant through its evolution into a libido pill.

Addyi (pronounced “addie”) is “our representation of Everywoman,” Sprout CEO Cindy Whitehead said of the pill’s brand name. “We hope to do something that really is a game-changer for women.”

If the drug is approved, Whitehead predicts Sprout, which has 31 employees, will “quadruple in size” by hiring drug sales reps to promote the pill to doctors who would prescribe it. Sprout has the ability to ramp up production quickly at facilities in Virginia and Georgia so that it can get the pills to patients this year, she said.

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