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Expert Commentary
Flibanserin is poised for FDA approval. But why this drug? And why now?
Dr. Simon is Clinical Professor, Department of Obstetrics and Gynecology, George Washington University, and Medical Director, Women’s Health & Research Consultants, Washington, DC. Dr. Simon is a North American Menopause Society past president, a certified menopause practitioner, and clinical densitometrist. Dr. Simon is an ISSWSH fellow and an AASECT certified sexuality counselor. He also serves on the OBG Management Board of Editors.
Dr. Simon reports that within the past 36 months, he has been a consultant to or served on the advisory boards of AbbVie, Actavis, Amgen, Amneal, Apotex, Ascend Therapeutics, BioSante, Depomed, Dr. Reddy Laboratories, Everett Laboratories, Intimina by Lelo, Lupin, Meda, Merck, Novartis, Noven, Novo Nordisk, Nuelle, Pfizer, Regeneron, Sanofi SA, Sermonix, Shionogi, Shippan Point Advisors, Sprout, Teva, TherapeuticsMD, Warner Chilcott, and Watson.
In the past 36 months, Dr. Simon has received grant/research support from AbbVie, Actavis, Agile Therapeutics, Bayer Healthcare, EndoCeutics, New England Research Institute, Novo Nordisk, Palatin Technologies, Teva, and TherapeuticsMD.
Within the past 36 months, Dr. Simon also has served on the speaker’s bureaus of Amgen, Eisai, Merck, Novartis, Noven, Novo Nordisk, Shionogi, Teva, and Warner Chilcott.
Dr. Simon served as Chief Medical Officer of Sprout Pharmaceuticals until April 1, 2013.
A long and winding road Flibanserin’s journey from inception to probable approval has been long and eventful, and you can be sure that the pharmaceutical industry has been paying attention. Hundreds of millions of dollars in funding for drug development hang in the balance. That women deserve remedies developed specifically for their needs and metabolism is a given. The approval of flibanserin will send a hopeful signal to them as well as to industry—that the FDA takes them seriously and seeks to identify effective remedies. In this case, it seems likely, the agency will end up on the right side of history.
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