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Drug execs behind female libido pill have run afoul of FDA

WASHINGTON — A small drugmaker from North Carolina may succeed next week where many of the world's largest pharmaceutical companies have failed: in winning approval for the first drug to boost women's sexual desire.

The husband-and-wife team that founded Sprout Pharmaceuticals is not new to the pharmaceutical business or even to marketing drugs to people frustrated with their sex lives. The couple's previous company, Slate Pharmaceuticals, sold an implantable testosterone pellet to men with low levels of the hormone.

But Slate's marketing push ran afoul of federal rules, making misleading, unsupported statements about the benefits of testosterone therapy while downplaying risks. In fact, when the Food and Drug Administration held a meeting examining the overprescribing of testosterone last year, it played Slate's commercial as an example of inappropriate marketing.

That record worries Sprout's critics, who see a troubling pattern in the aggressive tactics it has used to urge the FDA to approve the women's desire drug, which was previously rejected twice because of lackluster effectiveness and side effects such as nausea, dizziness and fainting.

The search for a pill to increase women's libido has been something of a holy grail for the pharmaceutical industry since the blockbuster success of Viagra for men in the late 1990s. Pfizer, Bayer and Procter & Gamble all studied — then abandoned — potential treatments for female sexual desire disorder.

"This company already has a history of unethical marketing," said Dr. Adriane Fugh-Berman of Georgetown University. "If approved, I think this drug will be widely prescribed, and we would see an epidemic of adverse effects."

After a year of lobbying by Sprout-backed supporters, the drug won a surprising 18-6 recommendation from a panel of FDA advisers in June. The FDA is scheduled to make its decision on the drug by Tuesday.

CEO Cindy Whitehead and her husband, Bob Whitehead, who preceded her as CEO, paid for the drug, dubbed Addyi, by selling off their testosterone business.

There is little financial information available about Slate or Sprout because they have both been privately held.

In March 2010, the FDA sent Slate an 11-page warning letter, highlighting a host of misleading, unsupported and inaccurate statements in its brochures, websites and a video.

Among the many problems, the company's website suggested Testopel could benefit patients with depression, diabetes and HIV.

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