Bioethics Blogs

So-called ‘female Viagra’ even less effective than suggested, not selling well

By: Elizabeth Yuko, Ph.D.

UPDATE: 2/29/16: An article published today in JAMA Internal Medicine found that Addyi — the so-called “female Viagra” —  is even less effective than initially thought, resulting in only one-half of one additional satisfying sexual experience per month for the women taking the medication.

The drug has not been selling well since it received FDA approval in August 2015. As of early January 2016, only 240-290 prescription for Addyi were written each week, according to a recent report cited in The New York Times. The report estimates that sales are currently running at a rate of around $11 million per year, far lower than the projected $100 to $150 million in revenue for this year.

For additional discussion of Addyi, the drug’s efficacy, and the ethical implications, please continue reading below.

 


ORIGINAL STORY: 8/21/15

Money can’t buy happiness, but evidently is instrumental in gaining FDA approval for controversial drugs with low efficacy and significant side effects.

On Tuesday, the U.S. Food and Drug Administration (FDA) approved Addyi (Flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, after denying approval in 2010 and 2013 because the risks of the medication did not outweigh the benefits.

The side effects, which include dizziness, sleepiness, nausea, fatigue, insomnia and dry mouth, are not only more prominent than the low levels of efficacy reported in the clinical trials, but are also exacerbated by the consumption of alcohol to such an extent that the FDA granted approval only with a risk evaluation and mitigation strategy (REMS) and a Boxed Warning – the strongest kind.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.