An FDA advisory panel voted against recommending that the agency approve Procter & Gamble's Intrinsa testosterone patch and said that additional safety data were needed, CBS MarketWatch and other news sources report. The drugmaker is seeking Intrinsa's approval for the treatment of hypoactive sexual desire disorder in surgically menopausal women.
Most of the panel agreed that even though the patch appeared to provide meaningful benefit in helping to enhance sex drive, the data from two six-month trials were inadequate to allow for a complete assessment of its long-term safety, CBS MarketWatch says.
Consumer groups also testified at the hearing and also voiced concern that not enough was known about Intrinsa's long-term health risks, as reported in Morningstar. Three women testified that they had developed breast cancer while using the patch and FDA medical officer, Lisa Soule, said that the breast cancer cases were evidence of the limitations of short-term study of the patch. She said that Procter & Gamble's plans for a post-marketing study that would compare 5500 women expected to use Intrinsa for the first year, against a database of 10 million patients for cancer and cardiovascular disease rates were inadequate, as reported in USA Today.
But Procter & Gamble's senior director of new drug development, Joan Meyer noted: "It is not uncommon to have unanswered safety questions at approval." And she added that safety data on about 200 women who used the patch for one year would soon be available, and the drugmaker would also further provide data for 100 women who have used Intrinsa for 18 months. So far, 80 women have used it for three years, according to the drugmaker.
The drugmaker also told the FDA advisors that there were no safety concerns seen in any of Intrinsa's clinical trials, and "urged the panel not to delay approval of the first drug for female sexual dysfunction," as reported in USA Today.
The decision is seen as a setback not just to Procter & Gamble, and Watson, which licensed the drug, "but also to a host of other companies working on drugs to treat diminished sexual desire in women," TheStreet reports.
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