The Food and Drug Administration (FDA) panel have backed Flibanserin ‘Female Viagra’, an experimental drug intended to boost the female sex with a safety restriction caution. The FDA had rejected the approval of the drug twice since 2010, according to theGuardian.
The FDA panel voted 18-6 in favor of approving the Sprout Pharmaceutical’s daily pill on the condition that its manufacturer develops a plan to limit safety risks.
The drug’s manufacturer and a coalition of women’s groups advocated for approval of the pill, while others advised agencies to remain cautious. Government health experts are backing drive, but reiterated that it must carry safety restrictions to manage potential side effects including fatigue, low blood pressure and fainting.
The vote was preceded by testimony from women who urged the agency to approve the drug and described their fears of never being able to have sex again.
“I should be able to determine if Flibanserin is worth the benefit of treatment,” said Amanda Parrish, one of more than 11,000 women who participated in a clinical trial of the pill.
Parrish said she began experiencing low libido during her second marriage and therefore decided to participate in the clinical trial.
“What a relationship-saving eight months that was,” she said.
Flibanserin does not work in the same way as Viagra, which increases blood flow, a simple biological function. Flibanserin, which was first studied as an antidepressant, changes brain chemistry. For that and other reasons, a coalition led by the National Women’s Health Network opposes approval of the drug.
“The problem with Flibanserin is not gender bias at the FDA but the drug itself,” the group said in a letter to the FDA.
In 2010, Flibanserin was rejected unanimously by an FDA panel, which said its benefits did not outweigh its risks, which can include low blood pressure and fainting spells. Sprout pharmaceutical company then picked up the drug in 2011 after it was dropped by its initial developer, Boehringer Ingelheim. They submitted it to the FDA again, and in October 2013 it was rejected again.
“The fundamental question is whether these observed placebo-corrected treatment effects outweigh the risks associated with treatment,” the FDA said in its latest review.
