Female sexual dysfunction company to keep fighting for its pill

Having taken on the development of flibanserin from Boehringer Ingelheim and put the drug for a problem with female libido through a new programme of clinical development, Sprout Pharmaceuticals has entered into a dispute process with the FDA.

The once-daily pill for hypoactive sexual desire disorder in premenopausal women has once before failed to impress a panel of the regulator’s advisers when approval was sought in 2010, then by Boehringer Ingelheim.

After 14 new clinical studies involving over 3,000 new patients, Sprout Pharmaceuticals has failed to improve the drug’s position, saying it has received a complete response letter from the FDA rejecting the treatment once more. The company says it has appealed this decision by entering into the regulator’s formal dispute process.

“Sprout strongly believes that it has satisfied the statutory requirements for approval of flibanserin.

“In clinical trials, flibanserin has outperformed placebo with statistical significance and, importantly, women treated with flibanserin perceived their improvement to be clinically meaningful. What the [FDA] division characterizes as a modest effect in their risk/benefit evaluation, we see as meaningful effect on the hallmark characteristics of the condition.”

Cindy Whitehead, president and chief operating officer, Sprout Pharmaceuticals.

The North Carolina, US-based company says it “sprouted out of Slate Pharmaceuticals in 2011” and “is focused solely on the delivery of a treatment option for the unmet need of millions of women with HSDD” (hypoactive sexual desire disorder).

Related news:

FDA says female sexual dysfunction pill may not be so hot (Pharmalot)

Female libido drug remains in limbo (Journal Review/Associated Press)

Reference links:

Sprout Pharmaceuticals appeals FDA decision on new drug application for flibanserin (Sprout Pharmaceuticals press release, December 11th)

Background document for flibanserin’s 2010 filing (FDA)

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