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

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Abstract

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.

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Notes

  1. BI development of flibanserin was halted in October 2010 following a negative evaluation by the U.S. Food and Drug Administration.

  2. Eight months earlier as Valeant’s difficulties became public, the highly effective former Sprout CEO (who had been contracted by Valeant to run the Division responsible for Addyi) resigned from Valeant reportedly under amicable circumstances.

References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

  1. Perelman MA. The history of sexual medicine. In: APA handbook of sexuality and psychology, Contextual approaches, vol. 2. Washington: American Psychological Association; 2014. p. 137–79. doi:10.1037/14194-005. While the biased perspective of an American psychologist is evident, the chapter is an excellent summation of the mid-century to present history of modern sexual medicine.

  2. https://en.wikipedia.org/wiki/Flibanserin#cite_note-StahlSommer2011-18; Retrieved 2016_03_27

  3. //eventhescore.org; Retrieved 2016_03_27

  4. //www.latimes.com/opinion/op-ed/la-oe-laan-tiefer-pink-viagra-20141114-story.html

  5. //www.fda.gov/newsevents/newsroom/pressannouncements/ucm458734.htm, accessed 2016_03_27

  6. Stahl SM, Sommer B, Allers KA. Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorder. J Sex Med. 2011;8(1):15–27.

    Article  CAS  PubMed  Google Scholar 

  7. https://addyi.com; Retrieved 2016_03_27.

  8. Joffe HV, Chang C, Sewell C, Easley O, Nguyen C, Dunn S, et al. FDA approval of flibanserin – treating hypoactive sexual desire disorder. N Engl J Med. 2016;374(2):101–4. doi:10.1056/NEJMp1513686.

    Article  PubMed  Google Scholar 

  9. Loes J, Frederik F, Bramer WM, Franco OH, Peter L, Laan ETM. Efficacy and safety of flibanbserin for the treatment of hypoactive sexual desire disorder in women: a systematic review and meta- analysis. JAMA Intern Med. 2016. doi:10.1001/jamainternmed.2015.8565.

    Google Scholar 

  10. https://www.youtube.com/channel/UC0Is15gTK3Ux9iw1GZR7NMg, Retrieved, 2016_03_28

  11. Parish, Sharon (personal communication, 3/28/2016), NAMS Commentary

  12. //www.forbes.com/sites/davidkroll/2015/08/20/wsj-valeant-to-acquire-libido-pill-maker-for-1-billion/#4cdb3d7b3b6a; Retrieved 2016_03_27

  13. Kaschak E, Tiefer L, Tiefer L. A new view of women’s sexual problems. New York: Haworth Press; 2001. Provides a good summary of the “new view...”.

  14. //www.newviewcampaign.org/, Retrieved 2016_03_27

  15. //fortune.com/2016/03/25/sprout-valeant-addyi/?xid=smartnews; Retrieved 2016_03_27.

  16. https://www.addyirems.com/AddyiUI/rems/pdf/addyiREMSProgramPrescriberandPharmacyTrainingIncludingaKnowledgeAssessment.pdf, Retrieved 2016_03_27.

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Acknowledgments

The author acknowledges the helpful reviews provided by Drs Sharon Parish and Alexander Pastuszak of an earlier version of this manuscript.

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Correspondence to Michael A. Perelman.

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Michael A. Perelman is the Founder of the MAP Educational Fund a 501(c)(3) public charity. Both he and/or his relatives intermittently maintain modest stock ownership in multiple pharmaceutical and biotech companies including, but not limited to: Lilly, Pfizer and Valeant.

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This article does not contain any studies with human or animal subjects performed by any of the authors.

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Perelman, M.A. What History Can Teach Us About the Different Response to the Launch of Addyi Versus Viagra. Curr Sex Health Rep 8, 116–120 (2016). https://doi.org/10.1007/s11930-016-0075-0

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