An FDA advisory panel rejected Procter & Gamble's application for approval of Intrinsa, a transdermal testosterone patch to treat low sexual desire in postmenopausal women.
December 1, 2006 (Press Release) --
Almost two years ago, an FDA advisory panel rejected Procter & Gamble's application for approval of Intrinsa, a transdermal testosterone patch to treat low sexual desire in postmenopausal women.
The panel based its rejection on insufficient long-term safety data for the product. In my opinion, the new drug was being held to a much higher safety standard than any other drugs the FDA had reviewed. (In the interest of full disclosure, I note that I have been a clinical investigator and consultant to Procter & Gamble on the Intrinsa program.) Here is my view of the true reasons for this delay.
At the time of Intrinsa's rejection, the FDA was in the throes of heavy criticism. In the air were reports of serious side effects from Vioxx and other COX-2 inhibitors used to treat arthritis. SSRI antidepressants were implicated in adolescent suicides. Hormone replacement therapy was under suspicion (based on premature and, in my view, incomplete data from the Women's Health Initiative) of increasing the risk of heart attacks and breast cancer in menopausal women taking this therapy.
Two years have passed and some of these issues have faded into background concerns. Vioxx was withdrawn from the market. The initial media frenzy associated with the results of the Women's Health Initiative study died down after careful analyses have shown that the women in the study were not representative of most menopausal women and the risks for women early in menopause are much lower than early reports indicated. And although the controversy continues, "black box" labels for prescription SSRI antidepressants urge caution in their use by children and adolescents.
Still, there are no approved drugs for women's sexual problems. There are some bright spots, however. Procter & Gamble will be introducing Intrinsa in Europe very soon. The company continues to collect solid safety data on the product and is working with the FDA to find a compromise solution that could lead to approval of the drug in the United States.
Other drugs to treat women's sexual dysfunctions are also in development. Several that act directly on the brain and central nervous system are now about to enter Phase III trials (the last stage of testing before FDA approval may be granted).
Until new drugs for women are approved, women are left to use unregulated, locally compounded products or testosterone gels designed for men. I hardly consider these alternatives safe or optimal.
I believe an important step is for women to take up their own cause and refuse to allow women's sexual problems to be trivialized as "lifestyle" problems. Men's sexual problems are not treated this way.
If a physical disease or disability is allowed to be dismissed as a matter of lifestyle, then it follows that treatments for that condition are held to a higher safety standard because a non-life-threatening condition, by clinical logic, does not justify much risk.
source: http://health.yahoo.com/
The panel based its rejection on insufficient long-term safety data for the product. In my opinion, the new drug was being held to a much higher safety standard than any other drugs the FDA had reviewed. (In the interest of full disclosure, I note that I have been a clinical investigator and consultant to Procter & Gamble on the Intrinsa program.) Here is my view of the true reasons for this delay.
At the time of Intrinsa's rejection, the FDA was in the throes of heavy criticism. In the air were reports of serious side effects from Vioxx and other COX-2 inhibitors used to treat arthritis. SSRI antidepressants were implicated in adolescent suicides. Hormone replacement therapy was under suspicion (based on premature and, in my view, incomplete data from the Women's Health Initiative) of increasing the risk of heart attacks and breast cancer in menopausal women taking this therapy.
Two years have passed and some of these issues have faded into background concerns. Vioxx was withdrawn from the market. The initial media frenzy associated with the results of the Women's Health Initiative study died down after careful analyses have shown that the women in the study were not representative of most menopausal women and the risks for women early in menopause are much lower than early reports indicated. And although the controversy continues, "black box" labels for prescription SSRI antidepressants urge caution in their use by children and adolescents.
Still, there are no approved drugs for women's sexual problems. There are some bright spots, however. Procter & Gamble will be introducing Intrinsa in Europe very soon. The company continues to collect solid safety data on the product and is working with the FDA to find a compromise solution that could lead to approval of the drug in the United States.
Other drugs to treat women's sexual dysfunctions are also in development. Several that act directly on the brain and central nervous system are now about to enter Phase III trials (the last stage of testing before FDA approval may be granted).
Until new drugs for women are approved, women are left to use unregulated, locally compounded products or testosterone gels designed for men. I hardly consider these alternatives safe or optimal.
I believe an important step is for women to take up their own cause and refuse to allow women's sexual problems to be trivialized as "lifestyle" problems. Men's sexual problems are not treated this way.
If a physical disease or disability is allowed to be dismissed as a matter of lifestyle, then it follows that treatments for that condition are held to a higher safety standard because a non-life-threatening condition, by clinical logic, does not justify much risk.
source: http://health.yahoo.com/
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