Michael C Snabes1, Stephen M Simes. 1. Clinical Development, BioSante Pharmaceuticals, Inc., 111 Barclay Boulevard, Lincolnshire, IL 60069, USA. msnabes@biosantepharma.com
Abstract
INTRODUCTION: Despite a high prevalence of hypoactive sexual desire disorder (HSDD), no medical treatment is available in the United States for this condition. AIM: To identify the current prescribing pattern of off-label testosterone use in treating HSDD. MAIN OUTCOME MEASURES: Quantitation of Intercontinental Marketing Services (IMS) prescription data to identify testosterone prescriptions written for women and a summary of response to queries to opinion leaders and practicing physicians. METHODS: Interviews and an opinion poll of gynecologists and family medicine physicians on current medical treatment of HSDD. RESULTS: The IMS prescription review showed that: two million testosterone prescriptions were written for women in 2006 and 2007--many physicians have prescribed compounded testosterone. Based on a summary of the physicians' survey: on average, patients of all ages, but particularly menopausal women, have at least moderate awareness of HSDD. More than 80% of physicians believe there is a need or great need for a Food and Drug Administration- (FDA) approved HSDD treatment. Ninety percent of physicians surveyed would prescribe an approved HSDD product over currently prescribed therapy. CONCLUSIONS: In the context of increased regulatory scrutiny, increasing off-label use of testosterone, formulation and dosing issues, increased patient awareness of FSD and HSDD, and overall favorable physician sentiment, the completion of the LibiGel clinical development program and an FDA approval will meet the demand for the first safe and effective FDA-approved treatment of HSDD in postmenopausal women.
INTRODUCTION: Despite a high prevalence of hypoactive sexual desire disorder (HSDD), no medical treatment is available in the United States for this condition. AIM: To identify the current prescribing pattern of off-label testosterone use in treating HSDD. MAIN OUTCOME MEASURES: Quantitation of Intercontinental Marketing Services (IMS) prescription data to identify testosterone prescriptions written for women and a summary of response to queries to opinion leaders and practicing physicians. METHODS: Interviews and an opinion poll of gynecologists and family medicine physicians on current medical treatment of HSDD. RESULTS: The IMS prescription review showed that: two million testosterone prescriptions were written for women in 2006 and 2007--many physicians have prescribed compounded testosterone. Based on a summary of the physicians' survey: on average, patients of all ages, but particularly menopausal women, have at least moderate awareness of HSDD. More than 80% of physicians believe there is a need or great need for a Food and Drug Administration- (FDA) approved HSDD treatment. Ninety percent of physicians surveyed would prescribe an approved HSDD product over currently prescribed therapy. CONCLUSIONS: In the context of increased regulatory scrutiny, increasing off-label use of testosterone, formulation and dosing issues, increased patient awareness of FSD and HSDD, and overall favorable physician sentiment, the completion of the LibiGel clinical development program and an FDA approval will meet the demand for the first safe and effective FDA-approved treatment of HSDD in postmenopausal women.