Home Tags Posts tagged with "sprout pharmaceuticals"

sprout pharmaceuticals


The FDA has approved flibanserin, a desire-enhancing drug for women that has been dubbed “Female Viagra”.

The Sprout Pharmaceuticals drug recently passed an FDA advisory committee meeting.

The non-hormonal pill is designed to assist premenopausal women regain their desire by boosting levels of certain brain chemicals.

However, flibanserin has been criticized as having marginal effects.

Versions of the pill, which will be marketed as “Addyi”, have been submitted for approval in the past but never passed.

The drug was rejected by the FDA twice for lack of effectiveness with results experts admitted were “modest” and side effects like nausea, dizziness and fainting.

Photo AP

Photo AP

Originally the drug was produced by German company Boehringer Ingelheim. Sprout bought the drug from that company after it was turned down by the FDA.

Documents from the June 4 FDA advisory meeting describe the drug’s purpose as “treatment of hypoactive s**ual desire disorder (HSDD) in premenopausal women”.

Women would take it each night.

A doctor would have to determine whether a woman seeking the pill was suffering from a disorder characterized by a lack of desire, causing the woman distress.

Currently, there is nothing on the US market approved for treatment of HSDD or another condition, female s**ual interest/arousal disorder (FSIAD).

“This condition is clearly an area of unmet medical need,” the FDA documents said.

Sprout only has 25 employees. Large pharmaceutical companies like Pfizer, Bayer and Proctor & Gamble have all studied female desire disorder treatment but abandoned plans to pursue it.

Sprout’s CEO, Cindy Whitehead, told AP they would promote Addyi carefully.

“We would never want a patient who’s not going to see a benefit to take it and tell everyone it doesn’t work,” she said.

Lobbying by Sprout Pharmaceuticals was backed by the women’s rights group Even the Score, which has accused the FDA of gender bias by approving a number of drugs treating men’s issues without passing an equivalent for women.


A federal advisory panel has urged the Food and Drug Administration (FDA) to approve Sprout Pharmaceuticals’ flibanserin, nicknamed the “female Viagra”.

The experts backed flibanserin, but said it must carry warnings about strong possible side effects including fainting and tiredness.

By a vote of 18-6, the advisory committee to the FDA favored approval of the drug for women whose lack of s**ual desire was not attributable to other causes such as disease or relationship troubles, providing that certain steps were taken to limit the risks of the drug. Doctors might be required, for instance, to inform patients of potential side effects — like low blood pressure, fainting, nausea and dizziness — and physicians might have to become certified to prescribe the drug.

The final decision now moves to the FDA.

Now the drug could be approved by August 18, the FDA’s deadline for making a decision.Flibanserin female Viagra

The FDA has rejected the drug twice since 2010 but it usually follows the advice of its experts.

The agency has previously approved Viagra for men in 1999.

The move was immediately hailed by some women’s organizations. Their controversial campaign by to win federal approval was waged under the banner Even the Score, which accused the FDA of gender bias because it had approved Viagra and other drugs to help men while leaving women without options. The participants in the campaign had been brought together by a consultant to Sprout Pharmaceuticals, the developer of flibanserin.

According to experts, the drug has “modest results”, however, Dr. Julia Heiman of the Kinsey Institute at Indiana University said: “But on the other hand, even modest results can make a lot of difference when you’re at a certain point in the clinical problem.”

One patient who received the drug explained its appeal.

“For us, flibanserin is a relationship-saving and life-changing drug,” said Amanda Parrish.

Some criticized the campaign as providing cover for a drug with marginal effects.

“To approve this drug will set the worst kind of precedent – that companies that spend enough money can force the FDA to approve useless or dangerous drugs,” said, Dr. Adriane Fugh-Berman of Georgetown University, the New York Times reported.

If approved, flibanserin will be aimed at pre-menopausal women.