Female Viagra Coming Soon?

Viagra

Women avoid sex for a variety of reasons, including relationship issues, a real headache, fatigue and lack of desire. It is easier for them to fake it and get engaged than for a man, but a low libidio – whether prompted by time of month, menopause or disinterest – may be remedied with a pill in the future. A female version of Viagra, the pill men take to arouse interest, could have a partner female version coming soon. However, its efficacy is questionable.

The little blue pill may soon have a pink counterpart. Flibanserin, which would be sold as Addyi, was approved on Thursday, 18-6, by an advisory panel of outside experts recommending approval by the U.S. Food and Drug Administration (FDA). The move was hailed by women’s organizations as a step toward sexual equality by with a female counterpart to the widely prescribed Viagra possibly coming soon. However, others question whether the clinical studies really indicate that the pill is effective or if the panel and FDA are reacting to intense lobbying from the manufacturer, Sprout Pharmaceuticals Inc.

Sprout’s lobbying and publicity campaign, called “Even the Score,” has been trying to guilt the FDA into approving the medication, which has been rejected by the FDA twice already, on the basis of discrimination. Their Web site notes that there have been 26 drugs for sexual dysfunction in men approved by the FDA (41 including generic versions); none have been approved to date for women.

The company and FDA acknowledge that millions of women suffer from various type of sexual dysfunction. Susan Scanlan, chairwoman of the “Even the Score” effort noted, “Yesterday’s decision by the FDA Advisory Committee was a validation of…this very real need.” She also claimed that the decision supports the science behind flibanserin.

Testing of the drug, however, did not show a strong effect on libido. Three clinical trials of the “female Viagra” produced consistently lukewarm results. Prior to taking flibanserin, the women in the study had, on average, two or three “sexually satisfying events” each month. Once they began taking the drug, the number of sexual events they experienced did increase, but only one event more per month than women who got placebos in the trial experienced. Both groups claimed they felt more desire, which the people getting the actual drug just slightly higher on questionnaires than those given a placebo.

The medication also created side effects, including low blood pressure and fainting. The side effects were not commonly experienced, but the critics maintain they — along with the lack of significant improvement in desire shown by the testing — are the reasons the pink pill has not been approved.

Michele Orza, a consumer representative on the advisory committee, was one of the people who has voted against approval. She maintains that women with low desire “deserve better” solutions.

One women who appeared at the approval hearing talked about how much low sexual desire is affecting her life and marriage. She argued that even a modest improvement would be welcomed. It should be noted, however, that her appearance and travel costs were paid from by Sprout and that she was not involved in the clinical trials.

When asked why flibanserin should get approval this time given the two prior rejections, Sprout leader Cindy Whitehead said it was  “really putting the patient voice at the center of it.” It would be nice to believe Sprout has women’s best interests in mind. The reality is that there is big money involved. Pfizer Inc., which manufactures Viagra, and Eli Lilly & Co., which makes competitor drug Cialis, reportedly had $3.98 billion combines in sales last year. Sprout did not even develop the pink pill. Boehringer Ingelheim did, but gave up on the medication and sold the future rights to Sprout after the first FDA rejection.

If flibanserin does get FDA approval this time, many do believe other more effective drugs will follow, particularly if the market is ripe. So, whether the pink pill being touted as the “female Viagra” is effective or not, the dialog about female sexual problems is likely to soon lead to a better solution coming in the future.

By Dyanne Weiss

Sources:
New York Times: ‘Viagra for Women’ Is Backed by an F.D.A. Panel
Bloomberg: ‘Female Viagra’ May Be More Marketing Than Science
CNN: ‘Female Viagra’? Women should be able to choose

Your Thoughts?