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December 16, 2013 Dr. Janet Woodcock (janet.woodcock@fda.hhs.

gov) Division of Drug Information (CDER) 10001 New Hampshire Avenue Hillandale Building, 4th Floor Silver Spring, MD 20993 Re: Flibanserin 22-526 Dear Dr. Woodcock: In our position as President, President-Elect, Immediate Past President, and former Past President of the International Society for the Study of Womens Sexual Health (ISSWSH), we are writing on behalf of our concerned membership. ISSWSH is the largest international, professional, multi-disciplinary, academic and scientific organization solely focused on female sexual function and dysfunction including: Providing opportunities for communication among scholars, researchers and practitioners about womens sexual function and sexual experience Supporting the highest standards of ethics and professionalism in the research, education and clinical practice of female sexual medicine Providing the public with accurate information about womens sexuality and sexual health. Our members are the international experts in the field of female sexual medicine, so, as you might imagine, we conduct much of the research for medical treatments that come to you for review and watch with interest your decisions that impact the women we treat. It is on that basis that we write today. We see that a dispute has been filed with the FDA over a treatment that could be the first drug approved for a common form of female sexual dysfunction, low sexual desire with accompanying distress. Many of our members have been investigators in flibanserins clinical trials, including the most recent pivotal trial where flibanserin met all three of its endpoints with statistical significance over placebo and the patients reported a meaningful response to the treatment. We know that data well and also what the women in the flibanserin trials shared as their personal experiences. Perhaps most importantly, we know what women who are affected by this condition deal with in terms of their personal and interpersonal distress. This is a life impacting condition that cannot go overlooked. Flibanserin had a public hearing in 2010 that informed what needed to happen for a successful path forward to approval. In the additional pivotal trial completed, flibanserin met its efficacy outcomes and further showed no difference in the side effect profile of dizziness, nausea, fatigue and somnolence from the previous two pivotal trials. We are

confused about the choice not to approve, again, given the positive results and safety profile. To be clear, we are not proponents of any one drug in particular. No single drug will ever be a cure-all in sexual or most other conditions, let alone effective for 100% of the appropriate patients. But that is never the standard by which biopsychosocial condition drugs are approved. We know that the male sexual dysfunction drugs are not a cure-all. They dont work for all men with the condition, they cant fix a relationship or psychological issue interfering with sex and they, too, have side effects that must be considered in the risk/benefit analysis. Yet there are 24 male sexual dysfunction drugs approved while weve been successful solely on painful intercourse (moderate to severe dyspareunia) in postmenopausal women and continue to debate what effect would be enough to approve a single pharmacologic option for HSDD, the most common female sexual complaint. Flibanserin has met its endpoints, has a safety profile that is well understood from multiple large scale trials and we all know there is a pervasive need so we urge you to reconsider giving women a treatment option of their own. Over 4,000 citizens have signed our WISH petition this year asking the same.


Andrew Goldstein, MD ( President, International Society for the Study of Womens Sexual Health (ISSWSH) Sharon Parish, MD ( President-Elect, ISSWSH Alan M. Altman, MD ( Immediate Past President, ISSWSH Sheryl A. Kingsberg, Ph.D. ( Former Past President, ISSWSH cc: Julie Beitz, MD, ODE III ( Hylton Joffe, MD, DBRUP (