Flibanserin and its discontents

Advisory Committee Meeting Document (2015) Flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women. Bone, Reproductive and Urologic Drugs Advisory Committee Meeting, Drug Safety and Risk Management Advisory Committee. p. i-xvi. http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/drugsafetyandriskmanagementadvisorycommittee/ucm449090.pdf. Accessed 6 Mar 2016 Althof SE, Rosen RC, DeRogatis L, Corty E, Quirk F, Symonds T (2005) Outcome measurement in female sexual dysfunction clinical trials: review and recommendations. J Sex Marital Ther 31:153–166 American Psychiatric Association (2000) Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Textual Revision. American Psychiatric Association, Washington DC American Psychiatric Association (2013) Diagnostic and Statistical Manual of Mental Disorders, 5th edn. American Psychiatric Association, Arlington BBC (2015, Aug 19) ‘Female Viagra’—a closer look at flibanserin. http://www.bbc.com/news/health-33984472. Accessed 6 Mar 2016 Bolton D (2008) What is mental disorder?: an essay in philosophy, science, and values. Oxford University Press, Oxford Brotto LA (2010) The DSM diagnostic criteria for hypoactive sexual desire disorder in women. Arch Sex Behav 39:221–239. doi:10.1007/s10508-009-9543-1 Clayton AH, Dennerstein L, Fisher WA, Kingsberg SA, Perelman MA, Pyke RE (2010) Standards for clinical trials in sexual dysfunction in women: research designs and outcomes assessment. J Sex Med 7:541–560. doi:10.1111/j.1743-6109.2009.01628.x Clayton AH, DeRogatis LR, Rosen RC, Pyke R (2012) Intended or unintended consequences? The likely implications of raising the bar for sexual dysfunction diagnosis in the proposed DSM‐V revisions: 1. For women with incomplete loss of desire or sexual receptivity. J Sex Med 9:2027–2039. doi:10.1111/j.1743-6109.2012.02850.x Derogatis LR, Komer L, Katz M, Moreau M, Kimura T, Garcia M Jr, Wunderlich G, Pyke R, VIOLET Trial Investigators (2012) Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. J Sex Med 9:1074–1085. doi:10.1111/j.1743-6109.2011.02626.x FDA (2015) ADDYI (flibanserin). FDA product labelling. p 3. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf. Accessed 26 Mar 2016 FDA (2016) CIALIS (tadalafil). FDA product labelling. p 17. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021368s027lbl.pdf. Accessed 4 Nov 2016 Gellad WF, Flynn KE, Alexander GC (2015) Evaluation of flibanserin: science and advocacy at the FDA. JAMA 314:869–870. doi:10.1001/jama.2015.8405 Goldschmidt D (2015, August 18) ‘Female Viagra’ gets FDA approval. CNN. http://www.cnn.com/2015/08/18/health/female-viagra-fda-approval/. Accessed 6 Mar 2016 Jaspers L, Feys F, Bramer WM, Franco OH, Leusink P, Laan ET (2016) Efficacy and safety of flibanserin for the treatment of hypoactive sexual desire disorder in women: a systematic review and meta-analysis. JAMA Intern Med 176:453–462. doi:10.1001/jamainternmed.2015.8565 Joffe HV, Chang C, Sewell C, Easley O, Nguyen C, Dunn S, Lehrfeld K, Lee L, Kim MJ, Slagle AF, Beitz J (2016) FDA approval of flibanserin—treating hypoactive sexual desire disorder. N Engl J Med 374:101–104. doi:10.1056/NEJMp1513686 Katz M, DeRogatis LR, Ackerman R, Hedges P, Lesko L, Garcia M Jr, Sand M, BEGONIA Trial Investigators (2013) Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial. J Sex Med 10:1807–1815. doi:10.1111/jsm.12189 Kingsberg SA (2014) Attitudinal survey of women living with low sexual desire. J Womens Health (Larchmt) 23:817–823. doi:10.1089/jwh.2014.4743 Kingsberg SA, Althof SE (2011) Satisfying sexual events as outcome measures in clinical trial of female sexual dysfunction. J Sex Med 8:3262–3270. doi:10.1111/j.1743-6109.2011.02447.x Meixel A, Yanchar E, Fugh-Berman A (2015) Hypoactive sexual desire disorder: inventing a disease to sell low libido. J Med Ethics 41:859–862. doi:10.1136/medethics-2014-102596 Nagoski E (2015) Nothing is wrong with your sex drive. The New York Times. http://www.nytimes.com/2015/02/27/opinion/nothing-is-wrong-with-your-sex-drive.html. Accessed 2 Feb 2016 Stahl SM (2015) Mechanism of action of flibanserin, a multifunctional serotonin agonist and antagonist (MSAA), in hypoactive sexual desire disorder. CNS Spectr 20:1–6 Sungur MZ, Gündüz A (2014) A comparison of DSM-IV-TR and DSM-5 definitions for sexual dysfunctions: critiques and challenges. J Sex Med 11:364–373. doi:10.1111/jsm.12379 Thorp J, Simon J, Dattani D, Taylor L, Kimura T, Garcia M Jr, Lesko L, Pyke R, DAISY Trial Investigators (2012) Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study. J Sex Med 9:793–804. doi:10.1111/j.1743-6109.2011.02595.x US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER) (2000). Draft guidance for industry: female sexual dysfunction: clinical development of drug products for treatment. http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4082B1_02_C-FDA-Appendix-1.pdf. Accessed 6 Mar 2016 Yuko E (2015) The FDA, finances and feminism: why the third time was the charm for so-called ‘female Viagra’. The Huffington Post. 2015, August 24. http://www.huffingtonpost.com/elizabeth-yuko/the-fda-finances-feminism_b_8021828.html. Accessed 6 Mar 2016