BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) presented a LibiGel clinical study update at the 21st Annual Meeting of The North American Menopause Society (NAMS) on October 8, 2010, with more than 1,000 experts and practitioners in menopause and women's health in attendance.
“LibiGel® (testosterone gel) Safety Study Continues with a Low Rate of Cardiovascular and Breast Cancer Events.”
Michael Snabes, MD, PhD, BioSante's senior vice president of medical affairs, presented an update entitled, "LibiGel® (testosterone gel) Safety Study Continues with a Low Rate of Cardiovascular and Breast Cancer Events." LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is currently no FDA approved product. BioSante anticipates the submission of a new drug application (NDA) for LibiGel in 2011.
Dr. Snabes presented data, based on approximately 2,300 women in the safety study for an average of approximately 10.5 months each, showing there have been only 14 adjudicated cardiovascular (CV) events, a rate of approximately 0.65 percent, and only seven diagnoses of breast cancer, a rate of approximately 0.32 percent. "If testosterone increased CV disease, we would expect to see a higher CV event rate, especially since the study subjects are at the higher end of cardiovascular risk for the intended treatment population. Based on the safety seen to date, we believe that LibiGel will be the first product approved by the FDA to treat HSDD in menopausal women, also referred to as FSD," stated Dr. Snabes.
In addition, BioSante sponsored a symposium entitled, "Sexual Quality of Life with Aging." The moderator of the symposium was Steven R. Goldstein, MD, FACOD, CCD, NCMP, Professor of Obstetrics and Gynecology, New York University School of Medicine and the next president of NAMS. Jan L. Shifren, MD, NCMP, Associate Professor of Obstetrics, Gynecology, & Reproductive Biology at Harvard Medical School, and Director of the Menopause Program at Massachusetts General Hospital spoke on the "Prevalence of Sexual Function & Distress Across the Lifespan for Women." Sheryl A. Kingsberg, PhD, Division Chief, Obstetrics & Gynecology, Behavior Medicine at the University Hospitals Case Medical Center, and Professor, Case Western Reserve University in Cleveland, Ohio covered the topic entitled, "Treatment Options for Postmenopausal Women With Sexual Dysfunction."
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