@ Raleigh firm submits NDA for ‘female Viagra’ | SEBIO

Raleigh firm submits NDA for ‘female Viagra’

Posted by on Jul 1, 2013

RALEIGH, NC – A local company trying to put what drug experts hope could be the “female Viagra” on pharmacy shelves took a big step forward this week.

Raleigh-based Sprout Pharmaceuticals, a company focused on developing sexual disorder treatments for women, has resubmitted a New Drug Application and expects to hear back before the end of the year. If approved, flibanserin would be the first FDA-approved treatment for hypoactive sexual desire disorder in pre-menopausal women.

HSDD is a form of female sexual dysfunction where women experience decreased desire for sexual activity.

“In cases where there is a bio-chemical component to sexual dysfunction, women, unlike men, have no biopharmaceutical options,” says Sheryl Kingsberg, chief of behavior medicine at University Hospitals Case Medical Center and professor in reproductive biology and psychiatry at Case Western Reserve University School of Medicine. She calls Sprout’s treatment “encouraging.”

The news comes after the recent publication of positive results for a Phase 3 clinical trial involving more than 1,000 patients.

Cindy Whitehead, CEO of Sprout, says the study and other information included in the resubmission addresses the concerns already raised by the FDA.

“This additional data … Is responsive to feedback received by the FDA previously,” she says.

Sprout, which has raised a venture haul so far of more than $25 million, is led by Whitehead and her husband, Bob, who bought the drug candidate for an undisclosed sum in 2011.

Sprout’s last financing round had its first sale this month and has netted $4.8 million in equity so far, with $5.2 remaining.

The hope is that flibanserin could do financially for Sprout what Viagra did for Pfizer (NYSE: PFE).

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