FDA confronts the Addyi dilemma: Yes or no on female libido pill?

The FDA is scheduled to come up against its PDUFA deadline for a formal decision on Sprout Pharmaceuticals' female sexual dysfunction drug Addyi (flibanserin) tomorrow. And with mainstream media groups lining up for a share of the widespread public interest in this therapy, there's a whole new round of features and controversy to review in the lead-up to the regulatory ruling.

The AP's weekend coverage in anticipation of the FDA decision centers on the trouble Sprouts' founders have run into in their earlier work on a testosterone drug aimed to boost men's health. Cindy and Bob Whitehead used to run Slate Pharmaceuticals, and as anyone who listened in to the FDA panel review a month ago knows, the regulatory agency went after Slate for making what it called false and misleading claims.

Among the more outrageous claims, according to the AP, Slate touted their testosterone pill as a boon against depression, diabetes and HIV--as well as boosting men's libido. And the backlash made this campaign a cautionary tale in the troubled testosterone field, with the FDA citing it recently as an example of marketing overreach.  

Critics of Sprout--which are as numerous as the legions of groups that have been recruited to support the application--have seized on that run-in with the FDA in 2010 as a warning sign of what could come if the same team gets an approval for a drug sometimes dubbed the "pink Viagra" for women. Outside experts at the FDA voted to back an approval, but the agency is also being asked to make sure there are tight regulations regarding who can get this drug, provided the agency hands out an approval.

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

Of course, Addyi--an 5HT1A and 5HT2A receptor agonist--has already been rejected twice by the FDA, with the first rejection leading Boehringer Ingelheim to offload it in an out-licensing deal with Sprout.

To help persuade the FDA to change its stance on the drug, little Sprout--which hopes to have landed a blockbuster drug for the tiny company with little added trial work--has been closely linked to Even the Score, an advocacy group that includes paid consultants to the company which helped attract support from the National Organization of Women. Even the Score also spurred a wave of consumer advocacy by claiming that the FDA's approvals in this field have been unfairly concentrated on male libido pills--even though they work along dramatically different biologic pathways.

"We hope to do something that really is a game-changer for women," Cindy Whitehead tells the Charlotte Observer.

We'll see soon if the FDA agrees.

- here's the AP report
- here's the report from the Observer

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