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Female Viagra

HandelontheLaw.com Staff Writer

Monday, July 20, 2015



Female Viagra
Presciption Drugs

The third time was a charm for Flibanserin, a drug that finally won conditional approval by a Food and Drug Administration (FDA) Panel to treat female “Hypoactive Sexual Desire Disorder” (HSDD). HSDD basically means that a woman lacks sexual fantasies and a desire for sexual intercourse or low libido in women. Low libido is a problem experienced by sexually active women of all ages. According to Everyday Health, as many as 43 percent of women report experiencing some type of sexual dysfunction, low libido being the most prevalent, but in many cases, it happens for no apparent reason. Hormonal changes associated with pregnancy and menopause can cause decreased libido, as can stress and poor body image.

“Female Viagra” is actually a misnomer. While Viagra works on the arteries and muscles to make a penis rise. Flibanserin works on the mind and changes brain chemistry.

Flibanserin was developed by Boehringer Ingelheim and submitted to the FDA in 2009, which unanimously rejected it in 2010 because its benefits did not outweigh its risks of low blood pressure and fainting spells. Strike One.

The drug was then acquired in 2011 by Sprout Pharmaceutical Company, which resubmitted the drug to the FDA in 2013; however, the FDA rejected the drug again because the benefits did not seem to outweigh the risks. Strike Two.

Sprout Pharmaceutical Company resubmitted the drug to the FDA in 2014 and the FDA panel voted 0-18-6 for conditional approval. The vote was 0-18-6 because panel members had 3 choices:
A. Yes, with labeling alone to manage the risks
B. Yes, but only if certain risk management options beyond labeling are implemented
C. No
Nobody voted for yes with labeling alone; six voted no; 18 voted yes but only with certain risk management options.

While some women’s groups support the drug’s approval, a coalition headed by the National Women’s Health Network opposes approval. Their opposition is based on the drug’s change of brain chemistry, the mild benefits and the risks to women’s health.

In any event, the drug is a $50 million venture by private investors who have backed Sprout’s development and presentation of the drug.

I’m used to a “Thank God that’s over” comment from older women about sex. What is more, an informal survey was taken about whether women would be willing to take the drug every day in order to have sex 1 more time per month; 75.51% said no. I know my people. Still, I might be mistaken: perhaps Flibanserin will be a huge success.


By Kathy Catanzarite


Source: Kathy Catanzarite - Handelonthelaw.com Staff Writer

Note from HandelontheLaw.com: This article is to be used as an educational guide only and should not be interpreted as a legal consultation. Readers of this article are advised to seek an attorney if a legal consultation is needed. Laws may vary by state and are subject to change, thus the accuracy of this information can not be guaranteed. Readers act on this information solely at their own risk. Neither the author, handelonthelaw.com, or any of its affiliates shall have any liability stemming from this article.





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