Will We Ever See a Viagra for Women?

Women with low sexual desire have very limited options for addressing their concerns.
Women with low sexual desire have very limited options for addressing their concerns.
Men have numerous medical options (such as Viagra) for improving sexual performance and enjoyment, but women basically have none.

WebMD has reported that 43% of women experience sexual problems, including low sex drive, which is called “hypoactive sexual desire disorder” (HSDD) in clinical settings. HSDD is characterized by having few to no sexual desires or fantasies, and the results can be relationship problems and additional stress. Studies concerning a drug called flibanserin have been submitted to the US Food and Drug Administration for treatment of HSDD in women, but twice it has been rejected.

What Is Flibanserin?

First developed by a company called Boehringer Ingelheim, flibanserin was rejected by the FDA in 2010. At that time, Boehringer Ingelheim discontinued development of the drug. However, a company called Sprout Pharmaceuticals took over the drug in 2011, and resubmitted data to the FDA, including 14 new clinical studies on more than 3,000 new patients. Overall, more than 11,000 women have participated in flibanserin clinical trials.

Flibanserin works in an entirely different manner than drugs like Viagra that are used to treat erectile dysfunction (ED) in men. Flibanserin was initially investigated as a possible antidepressant, and is not a hormonal treatment. It does not appear to affect a woman’s fertility, nor does it interact with birth control pills. It increases the levels of neurotransmitters dopamine and norepinephrine, while lowering levels of serotonin. Excitatory activity in the brain is driven by dopamine and norepinephrine, while inhibitory activity is serotonin-driven. A balance between the two systems is important for healthy sexual response in women. Flibanserin modulates these neurotransmitters to produce higher sex drive. To be effective, it must be taken every day.

What Did Flibanserin Studies Show?

Studies of flibanserin showed an increase in “satisfying sexual events” in the women taking it.
Studies of flibanserin showed an increase in “satisfying sexual events” in the women taking it. 

In 2013, the Journal of Sexual Medicine reported that women taking flibanserin reported an average increase of 2.5 “satisfying sexual events” in four weeks. This compared to an increase of 1.5 sexually satisfying events in women who were taking a placebo. Evaluation of whether the improvement was meaningful to the women taking the drug showed a significantly higher rate of meaningful benefit to women who took flibanserin compared to the placebo group. Side effects were minimal, and mostly consisted of dizziness, sleepiness, and nausea. The average age of the women in the trials was 36.

How Did the FDA Respond?

The FDA rejected Sprout Pharmaceutical’s submission of study data on flibanserin, sending the company a Complete Response Letter (CRL) in October 2013 asking for more information before the drug could be approved. Sprout insists they have provided more than enough data for the FDA to approve the drug. The FDA accepted Sprout’s appeal of the decision on December 3, and plans to rule on it sometime in the first quarter of 2014. The chances, however, aren’t great: of the 17 appeals the FDA considered in 2012, 14 were denied.

Some women’s health researchers are furious at the FDA’s action. Dr. Irwin Goldstein, director of Sexual Medicine at Alvarado Hospital in San Diego, worries that the FDA’s decision could dash hopes for pharmacological treatments for low sexual desire in women, telling CNN, “It will go back to dark ages of saying, ‘This is all a relationship problem,’ even though we know it’s not.”

Are There Alternatives?

There really aren’t any good medical alternatives for women who want help with HSDD. Experimental treatments are in the works, including the drugs Lybrido and Lybridos, developed by Emotional Brain. But the company’s website has only spoken of “very promising” study results that will be published “soon.” Palatin Technologies is researching a drug called Bremelanotide, for men and women, though it has not completed Phase III trials, which are necessary for FDA approval.

Other attempts at treating HSDD have been disappointing too. Pfizer, manufacturer of Viagra, stopped working on a female version of the drug in 2004. Two large studies of testosterone gel for women made by BioSante Pharmaceuticals failed in 2011. A testosterone patch submitted by Proctor and Gamble to the FDA in 2004 was denied by the FDA due to questions about long term safety. In other words, the wait for a “female Viagra” could be longer than expected.

eDrugstore.com is committed to improving sexual health and satisfaction, and dispenses prescription drugs like Viagra, Cialis, and Levitra, plus nonprescription lifestyle products like Stimula for Men and Stimula for Women. eDrugstore.com is committed to the most stringent standards of customer privacy, speedy shipping, and secure online ordering.

Photo Credits: Witthaya Phonsawat / freedigitalphotos.net, photostock / freedigitalphotos.net

Leave a Reply

20 Pill Generic Viagra Offer