Policy & practice points

Will the first medication to treat low sexual desire in women be approved?

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By Susan Rawlins, RN, MS, WHNP-BC

Female sexual dysfunction (FSD) affects an estimated 43% of women in the United States.1 FSDs include impaired sexual interest/arousal disorder, sexual pain disorder, and orgasmic disorder. But the most common FSD by far is hypoactive sexual desire disorder (HSDD), reported by as many as 1 in 10 women.2 HSDD can be definitively diagnosed with reliable and validated screening tools.3 Women’s healthcare providers are on the front line in terms of caring for women with HSDD, but we lack FDA-approved options to provide relief for them.

But now there is hope. As the August 2015 issue of Women’s Healthcare: A Clinical Journal for NPs goes to press, the FDA will have made its decision regarding whether to approve flibanserin for the treatment of HSDD in premenopausal women. Flibanserin, a non-hormonal drug, is thought to work by correcting an imbalance in the levels of neurotransmitters in the brain that affect sexual desire.4 More specifically, flibanserin increases dopamine and norepinephrine, both of which drive sexual excitement, and transiently decreases serotonin, which drives sexual satiety/inhibition.

Two months ago, an FDA advisory committee voted to recommend approval of flibanserin to treat HSDD in premenopausal women. Although the FDA is not required to accept the advisory committee’s recommendation, the agency agreed to consider it as part of the new drug application review. Readers can check www.npwh.org for the latest information on the FDA decision.

During the open comment portion of the hearing prior to this vote, Gay Johnson, CEO of NPWH, spoke on behalf of the association and in support of both women with HSDD and the providers who struggle to treat these women every day. In her statement, Ms. Johnson said, “Women’s sexual health is complex and multidimensional and often overlooked in primary care because of many factors, including cultural conditioning of women and providers. Historically, women’s sexuality has been viewed as something tied to the obligation to have sexual relations for reproduction, but not the desire to have sexual relations to achieve personal pleasure. Thankfully, now, in the 21st century, women’s sexual health is seen as a valid component of overall wellness. Women’s sexual dysfunction is now recognized as a real health condition, of real women, that decreases quality of life and negatively impacts relationships.”

Ms. Johnson clarified that NPWH is not advocating for the approval of any specific drug. She stated, “Each HSDD medical treatment option should receive fair consideration and the side effect/adverse event profile evaluated while considering the significant impact of the condition. Women are intelligent, insightful decision makers and can be trusted to evaluate the risks of side effects/adverse events and the benefits of any treatment according to the impact of HSDD on their personal lives and relationships.”

In both its educational and advocacy endeavors, NPWH supports nurse practitioners in providing high-quality healthcare for women, which includes addressing their sexual health concerns. Our Women’s Sexual Health Course for NPs, offered for the first time in June 2014 and again in June 2015, has been extremely well received, filling to capacity several weeks ahead of time and garnering positive feedback from participants. Women’s Healthcare, our journal, includes a Focus on Sexual Health department article in each issue, and our annual conference always includes courses on sexual health topics. Our advocacy work is ever-present as we actively support evidence-based treatments for all FSDs.

As such, we applaud the FDA’s recognition of HSDD as a health problem that merits pharmacologic treatment and we encourage the FDA to consider approval of medications that have demonstrated efficacy and safety in treating women’s most common sexual complaint.

Susan Rawlins is Director of Education for the National Association of Nurse Practitioners in Women’s Health and a women’s health nurse practitioner at the Greater Texoma Health Clinic in Denison, Texas. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

References

1. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999;281(6):537-544.

2. Parish SJ, Rubio-Aurioles E. Education in sexual medicine: proceedings from the International Consultation in Sexual Medicine, 2009. J Sex Med. 2010;7(10):3305-3314.

3. Kingsberg SA, Woodard T. Female sexual dysfunction: focus on low desire. Obstet Gynecol. 2015;125(2):477-486.

4. Sprout Pharmaceuticals, Inc. FDA Advisory Committee Recommends Approval for Sprout Pharmaceuticals’ ADDYI™ (flibanserin) to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women. June 5, 2015. http://www.sproutpharma.com/news-center/

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