P&G withdraws Intrinsa filing

Healthcare giant, Procter & Gamble, has withdrawn its application for Intrinsa – its testosterone patch to treat menopausal sexual dysfunction, dubbed the "female Viagra" after failing in its bid to win Food and Drug Administration approval for the product earlier this month [[03/12/04a]], according to Industry reports. The FDA advisory committee unanimously rejected approving Intrinsa because of a lack of both efficacy and safety data. It was particularly concerned over a potential link to cardiovascular events and breast cancer, triggered by the findings of the Women’s Health Initiative study in 2002 linking hormone replacement therapy to such long-term complications [[10/07/02b]]. Questions were also raised over the product's efficacy, with the difference between placebo and Intrinsa being just one additional sexually satisfying episode per month. Citing a company spokeswoman, Reuters notes that the firm is planning to submit a new dossier with the FDA, which will include data from a 12-month clinical trial – other trials had been six months in duration. The application will also include data from trials involving naturally menopausal women. The spokeswoman told Reuters that the company had not met with the FDA since its advisory committee gave its decision, but the firm is hoping to meet with the agency early next year, but no date has been set.