Association of Reproductive Health Professionals

January 8, 2014 Janet Woodcock, MD ([email protected]) Division of Drug Information (CDER) 10001 New Hampshire Avenue Hillandale Building, 4th Floor Silver Spring, MD 20993 Re: Flibanserin, NDA 22-526 Dear Dr. Woodcock: I am writing on behalf of the board of directors, staff, and 12,000 clinical professional members of the Association of Reproductive Health Professionals to encourage approval of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women. ARHP is a non-profit professional association with a mission to educate all members of the health care team about best practices in sexual and reproductive health. We are dedicated to improving health care for women and men throughout their lives, and have trained over 90,000 clinicians over the past decade through accredited, evidence-based education programs. As you review flibanserin, we hope you will keep in mind that there is no approved treatment currently available for HSDD, a real condition that impacts many US women. ARHP was present at the public hearing back in 2010 and has closely followed the progress related to the recommendations of that advisory committee since. When we saw the recent publication of the additional flibanserin pivotal trial in the Journal of Sexual Medicine we were pleased to note consistent demonstration of efficacy on SSEs, positive results with the FSFI as measure of desire and consistent decrease in distress. We were also pleased to see that the well-tolerated safety profile remained unchanged from previous trials even with the more liberalized enrollment criteria. Approval would mark a significant step forward for women’s sexual health and ARHP continues to support it. Sincerely,

Wayne C. Shields President and CEO cc: Julie Beitz, MD, ODEIII ([email protected]) Hylton Joffe, MD, DBRUP ([email protected]) Marsha Henderson, Office of Women’s Health ([email protected])