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Intrinsa fails to impress FDA advisory panel.
1Steroid Research Laboratory, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts 02215, USA. rspark@caregroup.harvard.edu
International Journal of Impotence Research
|March 18, 2005
Summary
Female sexual dysfunction (FSD) treatments are in demand, but the FDA rejected Intrinsa, a testosterone patch for hypoactive sexual desire disorder. This decision highlights challenges in recognizing FSD as a medical discipline.
Area of Science:
- Sexual Medicine
- Endocrinology
Background:
- Female sexual dysfunction (FSD) lacks consistent recognition and data, despite public demand for treatments.
- The media has amplified interest in potential FSD therapies, creating a market for new drugs.
- The Food and Drug Administration (FDA) reviewed Intrinsa, a testosterone patch for hypoactive sexual desire disorder (HSDD) in surgically menopausal women.
Purpose of the Study:
- To provide an expert perspective on the FDA's decision regarding the Intrinsa new drug application.
- To update the medical community on current topics in sexual medicine, specifically FSD drug development.
Main Methods:
- Review of the FDA's decision-making process for Intrinsa.
- Expert opinion and analysis by an endocrinologist specializing in FSD.
Main Results:
- The FDA did not approve Intrinsa, despite available scientific data.
- This decision underscores the complexities and controversies surrounding FSD drug approval.
Conclusions:
- The rejection of Intrinsa highlights the challenges in establishing FSD as a recognized medical field.
- Further discussion and expert viewpoints are needed to navigate FSD treatment and regulation.
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