CINCINNATI, OH, September 21, 2004 - Procter & Gamble Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has granted priority review to an investigational female testosterone patch for the treatment of hypoactive sexual desire disorder (HSDD) in surgically menopausal women. If approved, this investigational patch will be called Intrinsa® (testosterone transdermal system).

HSDD is defined as a lack of sexual desire that causes a woman personal distress and is one of the most prevalent female sexual health problems.¹ HSDD can lead to feelings of unhappiness, concern and frustration, and negatively impact a woman's relationship with her partner. According to a recent study, an estimated one in three surgically menopausal women in the U.S. has low sexual desire and nearly half of these women report being concerned about it.²

The submission was based on data from two Phase III clinical trials presented at the 52nd Annual Clinical Meeting of The American College of Obstetricians and Gynecologists (ACOG) in May 2004, and the 86th Annual Meeting of The Endocrine Society (ENDO) in June 2004, respectively. In these two 24-week, randomized, double-blind, placebo-controlled, multi-center studies of over 1,000 surgically menopausal women with HSDD (INTIMATE SM 1, n=562; INTIMATE SM 2, n=533), the efficacy and safety of the female testosterone patch were evaluated. The women ranged from 20 to 70 years of age, and were receiving either oral or transdermal estrogen therapy.

P&G Pharmaceuticals formed a joint collaboration with Watson Pharmaceuticals, Inc., to develop the female testosterone patch.

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¹ Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the united states: prevalence and predictors. JAMA 1999;281:537-44.

² Leiblum S, Koochaki P, Rodenberg C, Rosen R. Prevalence of Low Sexual Desire and Sexual Activity Levels Among Populations of Menopausal Women. NAMS Oral presentation 2002.

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