FDA To Review P&G Female Sex Dysfunction Drug

U.S. regulatory reviewers on Wednesday said it was unclear if Procter & Gamble Co.'s testosterone patch for boosting sexual desire in women produces meaningful benefit or is safe over the long term. The Food and Drug Administration reviewers will ask an advisory panel on Thursday if more safety studies are needed before approval of the patch, according to a summary posted on the FDA's Web site. The patch, called Intrinsa, is being developed with Watson Pharmaceuticals Inc. . The patch delivers testosterone, a hormone involved in sex drive, through the skin. Two studies showed women treated with Intrinsa had about one more satisfying sexual experience over a four-week period than women given a dummy patch, the FDA reviewers said. "It is not clear that the differences are clinically meaningful," said the reviewers' memo posted at: http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4082b1.htm

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