Skip to main content
Log in

The Quest for a Prosexual Medication for Women

  • Current Controversies (P Kleinplatz and C Moser, Section Editors)
  • Published:
Current Sexual Health Reports Aims and scope Submit manuscript

Abstract

The recent failure of the professional and lay public to quickly widely adopt the newly approved prosexual drug for young women with acquired Hypoactive Sexual Desire Disorder (HSDD) stimulated this review focusing on the obstacles facing any candidate drug for women’s desire deficiencies. Because sexual desire is relational and contextual, it is inappropriate to compare prosexual drugs for women with the PDE-5i medications for men. Underlying the uncertainties about the best outcome measures to be used in prosexual women’s studies are four basic questions. Are all young women’s desire problems to be considered a disorder? Which of them, if any, represent a serious medical disorder? Does the source of a woman’s distress actually matter to the diagnosis and treatment of her circumstances? Are subjects included in the HSDD clinical trials representative of those in the community with acquired HSDD or Sexual Interest/Arousal Disorder (SIAD)? Advocates for the approval of future candidate agents, who are likely to greatly benefit financially from their drug’s clinical benefit, might consider discussing both the strengths and the limitations of their safety and efficacy findings. The controversies that occurred before and after the approval of flibanserin are better respected rather than dismissed as obstructionist.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

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

  1. Conti RM, Rosenthal MB. Pharmaceutical policy reform—balancing affordability with incentives for innovation. N Engl J Med. 2016;374(8):703–6.

    Article  PubMed  Google Scholar 

  2. Gellad WF, Flynn KE, Alexander GC. Evaluation of flibanserin: science and advocacy at the FDA. JAMA. 2015;314(9):869–70.

    Article  CAS  PubMed  Google Scholar 

  3. Jones DS, Podolsky SH, Greene JA. The burden of disease and the changing task of medicine. NEJM. 2012;366(25):2333–8.

    Article  CAS  PubMed  Google Scholar 

  4. Gellad WF, Flynn KE. Evaluation of flibanserin: science and advocacy at the FDA. JAMA Int Med. Published online February 29, 2016. doi:10.1001/jamainternmed.2016.0073

  5. Schulte B, Dennis B. FDA approves controversial drug for women with low sex drive. The Washington Post. 2015 http://www.washingtonpost.com/national/health-science/fda-approves-contraversial-female-viagra-drug/2015/08/1868d34eca-45f6-11e5-8e7d-9c033e6745d8_story.html. Accessed 1 Sep 2015

  6. Cooper EB, McBride J, Levine, SB. Does flibanserin have a future? Psychiatric Times. 2016. http://www.psychiatrictimes.com/login?referrer=http%3A//www.psychiatrictimes.com%2Fdoes-flibanserin-have-future

  7. Risen CB. The Sexual Narrative: A Story Waiting to be Told. In: Levine SB, Risen CB, Althof SE, editors. Handbook of Clinical Sexuality for Mental Health Professionals. New York: Routledge; 2016. p. 10–21.

    Google Scholar 

  8. Gao L, Yang L, Qian S Li T, Han P, Yuan J. Systematic review and meta-analysis of phosphodiesterase type 5 inhibitors for the treatment of female sexual dysfunction. Int J Gynaecol Obstet. 2015 Dec 17. doi: 10.1016/j.ijgo.2015.08.015. [Epub ahead of print]

  9. Schoen C, Bachmann G. Sildenafil citrate for female sexual arousal disorder: a future possibility? Nat Rev Urol. 2009;6(4):216–22. doi:10.1038/nrurol.2009.25.

    Article  CAS  PubMed  Google Scholar 

  10. Bradford A, Meston CM. Behavior and symptom change among women treated with placebo for sexual dysfunction. J Sex Med. 2011;8:191–201.

    Article  PubMed  Google Scholar 

  11. Kingsberg SA, Althof SE. Satisfying sexual events as outcome measures in clinical trial of female sexual dysfunction. J Sex Med. 2011;8(12):3262–70.

    Article  PubMed  Google Scholar 

  12. DeRogatis LR, Komer L, Katz M, et al. Treatment of hypoactive sexual desire disorder in premenopausal women: Efficacy of flibanserin in the VIOLET study. J Sex Med. 2012;9:1074–85.

    Article  CAS  PubMed  Google Scholar 

  13. Katz M, DeRogatis LR, Ackerman R, et al. Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial. J Sex Med. 2013;10:1807–15.

    Article  CAS  PubMed  Google Scholar 

  14. Thorp J, Simon J, Dattani D, et al. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study. J Sex Med. 2012;9:793–804.

    Article  CAS  PubMed  Google Scholar 

  15. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Text Revision. 4th ed. Washington: American Psychiatric Press; 2000.

    Google Scholar 

  16. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington: American Psychiatric Press; 2013.

    Google Scholar 

  17. Giraldi A, Kristensen E, Sand M. Endorsement of models describing sexual response of men and women with a sexual partner: an online survey in a population sample of Danish adults ages 20–65 years. J Sex Med. 2015;12(1):116–28.

    Article  PubMed  Google Scholar 

  18. Basson R, McInnes R, Smith MD, Hodgson G, Koppiker N. Efficacy and safety of sildenafil citrate in women with sexual dysfunction associated with female arousal disorder. J Wom Health & Gen-based Med. 2004;11:367–77.

    Article  Google Scholar 

  19. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999;281:537–44.

    Article  CAS  PubMed  Google Scholar 

  20. Resnick DB, McCann DJ. Deception by research subjects. NEJM. 2015;373(13):1192–3.

    Article  Google Scholar 

  21. Turner EH, Matthews AM, Linardatos E, Tell RA. Rosenthal R selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252–60. Evidence provided that the development of skepticism is a vital component of professional sophistication concerning the balance of strengths and weaknesses of pharmaceutical science.

  22. Goodyear D. Annals of Science: The stress test: rivalries, intrigue and fraud in the world of stem-cell research. The New Yorker. 2016:46-57. Lest one think that science is pure, honest, and data bound, it is important to read this article and perceive its description of dishonesties in the highest places of basic science.

  23. Althof SE, Symonds T. Partnering with the Pharmaceutical Industry: Cutting Edge Work. In: Levine SB, Risen CB, Althof SE, editors. Handbook of Clinical Sexuality for Mental Health Professionals. New York: Routledge; 2016. p. 371–5.

    Google Scholar 

  24. Moynihan R. Evening the score on sex drugs: feminist movement or marketing masquerade? BMJ. 2014;349:g6246. doi:10.1136/bmj.g6246.

    Article  PubMed  Google Scholar 

  25. Woloshin, S, Lisa M. Schwartz LM, (Editorial) US Food and Drug Administration Approval of Flibanserin: Even the Score Does Not Add Up JAMA Intern Med. Published online February 29, 2016. doi:10.1001/jamainternmed.2016.0073. Many are angry at the distorting advocacy process that was perceived as part and parcel of run up to approval. It should be noted that the company that purchased the rights to flibanserin has continued to suffer serious losses in the value of its stock.

  26. Joffe HV, Chang C, Sewell C, Easley O, Nguyen C, Dunn S, et al. FDA approval of flibanserin—treating hypoactive sexual desire disorder. NEJM. 2016;374(2):101–4. It is refreshing to read an historical account without passion about the numerous processes that lead to flibanserin’s rejections and ultimate approval in August 2015.

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Stephen B. Levine.

Ethics declarations

All reported studies/experiments with human or animal subjects performed by the authors have been previously published and were in compliance with all applicable ethical standards (including the Helsinki Declaration and its amendments, institutional/national research committee standards, and international/national/institutional guidelines).

Conflicts of Interest

SBL and DLS have been conducting male and female prosexual drug research sponsored by the pharmaceutical industry for 20 years. They were a site investigator team for one of the flibanserin trials. EBC has written an editorial about flibanserin but has not been an investigator.

Human and Animal Rights and Informed Consent

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

Additional information

This article is part of the Topical Collection on Current Controversies

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Levine, S.B., Sheridan, D.L. & Cooper, E.B. The Quest for a Prosexual Medication for Women. Curr Sex Health Rep 8, 129–135 (2016). https://doi.org/10.1007/s11930-016-0085-y

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11930-016-0085-y

Keywords

Navigation