What History Can Teach Us About the Different Response to the Launch of Addyi Versus Viagra

Over the last 6 months since Addyi’s launch, there have been a few attempts to explain the reasons for the apparently limited number of prescriptions being written and filled for Addyi to date. Interestingly, despite the low number of prescriptions and paucity of new data available, there does continue to be intermittent professional articles and Internet communications that both discourage and encourage the use of Addyi based on their respective analyses of earlier efficacy and safety data. Both sides weigh in on issues of medicalization, pharmaceuticalization, commercialization, and the question of sexism versus science. But missing from most of the diatribes is another reason for Addyi’s very slow uptake by the medical community related to the regulatory approval process itself, economic, and political forces, and most importantly historical factors that help account for the differentiated response to Viagra and Addyi. Sexual healthcare professionals in particular who share a common belief in multilevel causality would be remiss in not recognizing the extremely important historical differences and circumstances surrounding the launch of Viagra by Pfizer in 1998 and the launch of Addyi by Sprout (currently owned by Valeant Pharmaceuticals) in October, 2015. Analysis of the 1998 Viagra launch found in “The History of Sexual Medicine” (APA’s Handbook of Sexuality and Psychology) provides enhanced perspective about Addyi’s less-than-meteoric introduction, particularly given the substantial media buzz and publicity that surrounded Addyi’s convoluted and controversial path through the FDA. It is critical to recognize that in 2015 there was no large backlog of women already using FDA-approved sexual medicine drugs to treat their “FSD,” as none had been previously approved for that purpose. Unlike Viagra, there was no preexisting audience for the drug who could choose to substitute a new medical drug therapy for a noxious pharmaceutical regimen they were already using. Unlike Pfizer in 1998, Sprout lacked broad existing company/physician/patient relationships. Furthermore, post-launch regulatory limitations on marketing and advertising of Addyi make it much less likely that women who believe they suffer from HSDD symptoms would not necessarily be aware that a new treatment was available nor how to be evaluated or how to obtain it. Finally, FDA imposed provider and distributor certification requirements have exacerbated the situation at least presently. None of the above negates the importance of a continued, but professional and thoughtful debate over what type of therapy is the most appropriate, safe, and efficacious treatment for women.