The Pink Viagra Not Approved By The FDA?

A Food and Drug Administration (FDA) advisory panel has recommended that the FDA does not approve flibanserin, the female counterpart to Viagra. The panel said flibanserin failed to boost women’s sex drive as the drug manufacturer Boehringer Ingelheim said it would. Plus the drug’s tolerability was only moderate as the woman taking it reported depression, fainting, fatigue, as well as other issues.

The nicknamed pill, the Pink Viagra, will know it’s fate soon as the FDA advisory panel meets to see whether or not it will approve the once a day drug to help women with a low libido. The drug maker wants the FDA approval so it can start marketing Girosa, which will be the name of this new medication. If approved, Girosa will be sold in pill form with a prescription for the treatment of hypoactive sexual desire disorder.

Hypoactive sexual desire disorder is defined as healthy woman having a lack of sexual desire or low libido.

The major concern outlined to the advisory boards review is the fact that although the drug did increase the sexual experience, it did not increase the women’s sexual “desire”. This is considered a major discrepancy in Boehringer Ingelheim’s effectiveness data.

Does Flibanserin increase a womans sexual desire?

The drug makers study was to measure the effectiveness of increasing a woman sexual desire, which the studies simply did not achieve the advisory panel said.

And add the fact that sedation, drowsiness, and fatigue were commonly reported, plus the fact that not enough study has been established to measure the effect of the drug when taken with other medications makes it hard for the advisory board to recommend anything but not approving the drug. They are worried that warning labels alone will not be enough to properly advise against the safety issues if it were approved. These are big hurdles for Boehringer.

During the drug trails, almost 15% of the women stopped talking the drug before the study was completed due to these reported side effects. The mentioned side effects were more common then the ones reported for the placebo.

Women with a low libido have limited options for treatment

Boehringer Ingelheim is a privately held company in Germany. It reported that its studies and data shows a meaningful benefit for women with a low libido and have limited options available to them from the medical community. Women who took the drugs for 6 months reported an increase of satisfied sexual experiences, but the increase was marginal over the placebos. The average was 2.8, and increased to 4.5 with the drug, but also increased to 3.7 with the placebo.

Although the FDA makes the final approval, it typically takes the advice of the advisory panel. And because this is a once a day medicine, the long term effects with other drugs simply isn’t known. It’s a big difference compared to Viagra which is a take as needed before sexual intercourse drug. Viagra simply targets the blood vessels around the penis increasing blood flow needed to get and maintain an erection.

Its female counterpart, flibanserin (Girosa), acts on the neurotransmitters in the brain, an entirely different process than Viagra. And it must be taken daily to keep its effect working on the brain, which raises unanswered question on it’s long term use.