FDA Approves Flibanserin; Use May Be Limited

September 15, 2015
Nicole M. Lodise, Pharm.D., TTS

Hypoactive sexual desire disorder (HSDD) is defined as a decrease in or an absence of sexual desire or excitement for sexual activity that may result in personal distress and interpersonal difficulties.^1,2 Several agents have been investigated and studied off-label showing positive results, but a U.S. Food and Drug Administration (FDA)-approved option did not arrive on the market until recently. Flibanserin is a non-hormonal agent that acts primarily as an agonist and antagonist at the 5-HT1A receptor and 5-HT2A receptor, respectively, and has demonstrated possible benefit in female sexual functioning and desire in addition to improvements in sexual distress.³ The primary concern that has surrounded flibanserin is its adverse effect profile, including hypotension, syncope, and somnolence. Possible limitations on generalizability given the study populations led to two prior FDA denials in 2010 and 2013.⁴

After the second FDA denial, Sprout Pharmaceuticals acquired flibanserin from Boehringer-Ingelheim. In the past two years, data have been collected to respond to the FDA’s concerns with adverse effects, while at the same time, consumer advocacy groups have actively engaged the FDA regarding the need for an approved option.⁴ Despite the concern about adverse effects and limited generalizability, an advisory committee of the FDA voted 18 to 6 in June 2015 to recommend the approval of flibanserin as a treatment of HSDD in premenopausal women.⁵ Flibanserin demonstrates possible benefit in select populations, but with reported adverse effects. Therefore, it may be advantageous to limit its use in the broad population until further data are available. With this approval, pharmacists will have an opportunity to inform patients how this option works in comparison to other unapproved options and educate patients on the adverse effect concerns, but also to engage patients in a conversation about sexual health history. This approval creates a call for pharmacists to enhance their comfort level in discussing patient sexual health issues, provide education on patient-specific treatment options, and, most importantly, advocate for further detailed research into safe and effective options for women with sexual dysfunction.

Read more about treatment options for HSDD beyond testosterone.⁶

• ACCP Members: http://www.accp.com/1209m
• Nonmembers: http://www.accp.com/1209nm

References:

1. Sexual dysfunctions. In: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (DSM-5), 5th ed. Washington, DC: American Psychiatric Publishing, 2013:423-50.
2. Derogatis L, Clayton A, Lewis-D’Agostino D, et al. Validation of the Female Sexual Distress Scale-Revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med 2008;5:327-64.
3. Simon JA, Kingsberg SA, Shumel B, Hanes V, Garcia M Jr, Sand M. Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial. Menopause 2014;21:633-40.
4. Gellad WF, Flynn KE, Alexander GC. Evaluation of Flibanserin: Science and Advocacy at the FDA. JAMA 2015;314:869-70.
5. Roehr B. FDA committee recommends approval for “female Viagra.” BMJ 2015;350:h3097.
6. Lodise NM. Hypoactive sexual desire disorder in women: treatment options beyond testosterone and approaches to communicating with patients on sexual health. Pharmacotherapy 2013;33:411-21.

Dr. Lodise is an associate professor of pharmacy practice at Albany College of Pharmacy and Health Sciences in New York. As an expert in women’s health and tobacco cessation, she teaches across a variety of courses in the doctor of pharmacy curriculum and has research and publications in these areas.

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