Intrinsa fails to impress FDA advisory panel.
Female sexual dysfunction (FSD) as a discipline of medicine is not fully recognized by many authorities. Definitions are controversial and data are lacking, yet the public clamors for treatment. The lay press has capitalized on this provocative women's issue, seizing on the public's insatiable desire for new, potentially 'sexy' therapeutic options in this area. Thus, the time was ripe for a potential FSD drug. The sexual medicine community watched with interest as the Food and Drug Administration (FDA) considered the Proctor & Gamble new drug application for Intrinsa (a testosterone patch for hypoactive sexual desire disorder for women who had undergone surgical castration via bilateral oophorectomy). In spite of quality scientific data, Intrinsa was not approved. With this issue of IJIR, a new column, entitled, 'perspective' is provided to the readership. Perspective is an invited opinion or viewpoint that aims to advise and update the medical community on a pertinent or current topic in sexual medicine. Dr Richard Spark, a noted endocrinologist, presents the first of three invited 'perspectives' on Intrinsa and the FDA decision. Dr Spark has authored several manuscripts on the topic of FSD.
Spark
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Steroid Research Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts 02215, USA. rspark@caregroup.harvard.edu
D000279:Administration, Cutaneous; D000728:Androgens / Q000172:deficiency; D018849:Controlled Clinical Trials as Topic; D017277:Drug Approval; D005260:Female; D006801:Humans; D007880:Legislation, Drug; D010052:Ovariectomy / Q000009:adverse effects; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy* / Q000209:etiology; D013739:Testosterone / Q000008:administration & dosage* / Q000009:adverse effects; D014481:United States; D014486:United States Food and Drug Administration; D016387:Women's Health
D000728:Androgens; C503596:Intrinsa; D013739:Testosterone