According to an article published online by JAMA Internal Medicine (JAMA Intern Med. Published online February 29, 2016. doi:10.1001/jamainternmed.2015.8565) found that flibanserin (Addyi), which was approved last year by the FDA to treat hypoactive (low) sexual desire disorder (HSDD) in premenopausal women, had marginal clinical benefits and significant increases in some adverse events.
Loes Jaspers, M.D., of the Erasmus University Medical Center, Rotterdam, the Netherlands, and coauthors reviewed eight clinical trials (five published and three unpublished) that included 5,914 women to examine the efficacy and safety Addyi.
Here’s what they found.
In this 4-minute audio snippet, the authors summarize the results of their study and recommend changes in how the FDA approves drugs for unmet medical conditions, but which limited efficacy:
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Not mentioned by the authors is how Sprout – the company that brought Addyi to market – launched a ground-breaking patient campaign that played a major role in getting Addyi approved by the FDA. For more on that, read “The Power of Patient Input: How FDA Learned to Love & Approve Addyi“.
