“Female Viagra” Gets Support From FDA Advisory Panel, Recommended For Approval

The first pill considered as “female Viagra” is on its way to becoming available in the market, since a Food and Drug Administration advisory panel voted on Thursday the recommendation for approval. The meeting was held at the FDA campus in Silver Spring, Maryland where the committee voted 18 to 6 accompanied by a warning from the agency, according to the Washington Post.

The FDA advisory panel recommends Flibanserin’s manufacturer to highlight the side effects and drug interactions that come with the drug. The vote came after testimonials from women who pressed on the agency to give the drug a go and shared their fears of never being able to enjoy sex like they used to.

Different women’s groups, as well as the drug maker, support the approval of the “pink pill”. There are also other advocates for women’s health that advise the agency to remain cautious.

Flibansterin is a pill that should be taken at bedtime and is used to treat loss of libido in premenopausal women, which is not caused by disease and/or other known causes. It is manufactured by Sprout Pharmaceuticals that claimed seven percent of postmenopausal women experienced loss of libido, a condition also known as hypoactive sexual desire disorder.

According to sources, the drug has been rejected two times by the drug agency for the reason that the drug has more cons than pros. In 2010, the drug received its first rejection via a unanimous vote. The second time it was rejected was in 2013.

After being rejected twice, some women’s groups organised a campaign to urge the drug agency to approve the drug. The campaign accused FDA of gender bias because Viagra and other drugs for men’s libido were approved while women didn’t have anything to take.

After the Thursday vote, the advisory started on setting conditions for the approval if the drug manufacturer would give out warning labels, a certification, prescriber training and an education program. Sprout Pharma has announced on their official site that they will resubmit the drug application for flibanserin.

The FDA has also required the company to go through two additional Phase 1 trial for drug interaction and a Phase 1 “driving simulator study”.“We are encouraged by the FDA’s response and view it as a significant step toward the approval of flibanserin,” said Sprout Pharma president and CEO Cindy Whitehead.

To report problems or leave feedback on this article, email: wendylemeric@gmail.com.