Flibanserin – Female viagra drug waiting FDA approval

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Viagra is one of the most popular drugs in the market. It has been used by millions of men worldwide. After the great success of Viagra, many women were looking for options if they can have a women’s Viagra, a solution to their sex life. Recently a German drug company Boehringer Ingelheim comes with a new drug that can be used by premenopausal women who are distressed by low sexual desire or Hypoactive Sexual Desire Disorder (HSDD).

HSDD is the most commonly reported female sexual complaint. It is characterized by a decrease in sexual desire that causes marked personal distress and/or personal difficulties. According to prevalence studies about 1 in 10 women reported low sexual desire with associated distress, which may be HSDD.

The new drug contains flibanserin, which was originally designed to function as an anti-depressant has been suspected of having a positive effect on women who suffer from decreased desire for sexual activity.

 

This long awaited drug has recently completed the clinical trials and is being reviewed by FDA. In its review which is posted online, FDA has raised some major issues associated with the drug. Some of the major talking points are as follows:

  • Two studies failed to show a significant increase in sexual desire, though women did report more sexually...



    satisfying experiences.
  • About 15% of flibanserin users in the experimental trial stopped taking the drug because of severe side effects  like dizziness, nausea, anxiety and insomnia, compared to 7 percent of the placebo users.

FDA and its expert committee will vote on Friday June 18, 2010 whether or not to recommend approval of flibanserin.

I believe flibanserin would be a great hit for Boehringer Ingelheim, if they get the approval from FDA. Considering the results of clinical trials and side effects, it is challenging for FDA to evaluate the risks and benefits of the drugs according to need in the market. In past we have seen several cases when FDA approved the drugs like valdecoxib, celecoxibs and others, which were withdrawn from the market after few years due to their life threatening side effects.  Given the side effects, I would certainly recommend consulting your doctor if you decide to go for it, once approved.

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