WASHINGTON, JUNE 4, 2015 – Even the Score today issued the following statement following a historic decision by an Advisory Committee of the Food and Drug Administration (FDA) to recommend approval of what would be the first-ever medical treatment option for women’s most common sexual dysfunction, Hypoactive Sexual Desire Disorder (HSDD). The Agency will issue its final decision on the drug, flibanserin (Addyi), in August.
From Susan Scanlan, Chair of Even the Score and Chair emerita of the National Council of Women’s Organizations:
“The FDA Advisory Committee made history for women’s sexual health today by choosing to respect the science and stand with the millions of American women suffering from HSDD by opening the door to medical treatment options for their most common sexual dysfunction. They rejected an unsustainable status quo where women have ZERO medical treatment options for their condition – while at the same time men enjoy 26 options marketed for their own sexual dysfunction.
“The Advisory Committee’s recommendation has historic repercussions – first, for the 1-in-10 women who are living with HSDD without a single approved medical treatment for their condition. And second, it will mean the difference between opening a pipeline of future options for women’s sexual health and closing it for good.
“The science is clear on flibanserin: It has been tested in more than 11,000 women – making it one of the most studied women’s health products in history; its safety is well characterized, as the most common side effects include dizziness, sleepiness and nausea; and the women in the trials themselves said the effects were “meaningful” using the scientific tool that the FDA required.
“Women with HSDD deserve the safety and peace of mind that comes with access to FDA-approved medical treatment options, and today we write a new chapter in the fight for equity in sexual health. We applaud the FDA’s recognition of female sexual dysfunction as a key unmet medical need. We urge the FDA to make in history in August by issuing final approval of the first-ever medical treatment option for women’s most common sexual complaint.”
Over the last year, there has also been a steady drumbeat of support for women’s sexual dysfunction treatment options from lawmakers, women’s rights groups, medical experts and consumer organizations. Earlier this year, 11 members of Congress urged the FDA “to continue your focus on providing women with safe and effective treatments they need and deserve.” Last year, four Congresswomen voiced their concerns about the lack of sexual dysfunction treatment options for women. Leaders from the National Organization for Women, the National Consumers League, the International Society for the Study of Women’s Sexual Health, the Memorial Sloan-Kettering Cancer Center and the Center for Health and Gender Equity have also penned letters to the FDA raising similar concerns with the FDA’s failure to provide treatment options to women struggling with sexual dysfunction.
Even the Score is an advocacy campaign created to serve as a voice for American women and couples who believe that it’s time for the FDA to level the playing field when it comes to the treatment of hypoactive sexual desire disorder (HSDD).
Supporters of Even the Score include: American College of Nurse-Midwives; American Sexual Health Association; Association of Reproductive Health Professionals; Black Women’s Health Imperative; CHANGE: Center for Health and Gender Equity; EmpowHER; HealthyWomen; HisAndHerHealth.com; International Society for the Study of Women’s Sexual Health; Jewish Women International; National Council of Women’s Organizations; National Women’s Health Resource Center; Middlesex MD; National Association of Clinical Nurse Specialists; National Association of Nurse Practitioners in Women’s Health; National Hispanic Medical Association; Sexual Medicine Society of North America; Society for Women’s Health Research; Sprout Pharmaceuticals; Red Hot Mamas; The Blue Thong Society; The Institute for Sexual Medicine; The Women’s Research & Education Institute; and Trimel Pharmaceuticals.
To learn more about the work of Even the Score: www.EvenTheScore.org.