Friday, July 20, 2018
Stay connected with us

Home > Drugs/Therapy

FDA Reports More Info Needed on “Female Viagra”

Update Date: Feb 12, 2014 11:28 AM EST
Close

Over the years, drug-manufacturing companies have developed ways of improving people's sex lives, particularly for men. Since men are not the only ones that deal with sexual performance issues, some companies have tried to create a drug for women. Sprout Pharmaceuticals attempted to get its "female Viagra" approved last year. The United States Food and Drug Administration (FDA) rejected the application then and now, the agency has requested the company to provide more information on the drug.

"The FDA has requested that Sprout complete two additional Phase I drug interaction studies and a Phase I driving simulator study," the company announced according to CNN.

The drug, fibanserin was created to treat women with low libidos, scientifically called Hypoactive Sexual Desire Disorder. It aims to increase sexual desire and improve overall sexual health. Sprout first submitted an application to the FDA for approval last year. The FDA rejected the application but provided the company "clear guidance" on how it can move forward toward potential approval. The additional tests that the FDA wants the company to conduct will examine the effects of the drug on driving. The tests will also analyze different enzyme pathways.

"We are encouraged by the FDA's response and view it as a significant step toward the approval of flibanserin," said Cindy Whitehead, president and chief operating officer of Sprout Pharmaceuticals.

Fibanserin was first developed by Boehringer Ingelheim, which gave up on the drug after its application was dismissed in 2010. The FDA had wanted more information on the drug. In 2011, Sprout took over the research and submitted 14 new clinical studies involving over 3,000 new patients. Overall, more than 11,000 people have participated in these trials. However, the FDA stated that the findings suggest only a "modest" effect. Many women's groups that are advocates for this drug have claimed that the FDA is being biased.

"When it comes to approving drugs for male sexual dysfunction, the FDA says yes with more limited research and serious side effects, but when it comes to women, their go-slow tactics are preventing us from having access to a treatment option where we make the decision in consultation with our healthcare provider," said Terry O'Neill, president of the National Organization for Women reported by Reuters Health.

The FDA has stood by its decision and stated that the evidence provided to them does not suggest that the side effects outweigh the benefits. The agency added, "All drugs need to show positive benefit when compared to risk."

Sprout Pharmaceuticals announced that it plans on reapplying by the third quarter of this year.

See Now: What Republicans Don't Want You To Know About Obamacare

Get the Most Popular Stories in a Weekly Newsletter
© 2017 Counsel & Heal All rights reserved. Do not reproduce without permission.

Join the Conversation