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Title: AUA MEETING: Uprima Shows Promise In Patients With Erectile Dysfunction
URL: http://www.pslgroup.com/dg/FBCEA.htm
Doctor's Guide
May 5, 1999


DEERFIELD, IL -- May 5, 1999 -- Data from three Phase III studies presented yesterday at the American Urological Association meeting in Dallas, TX., suggest that TAP Pharmaceuticals' dopamine receptor agonist, Uprima(TM) (apomorphine HCL tablets) sublingual, can increase the number of successful intercourse attempts.

Uprima is a central initiator that works by stimulating an erection through mechanisms originating in the brain.

"The results of this study are promising and provide hope for the approximately 30 million Americans who suffer from some form of erectile dysfunction," said Harin Padma-Nathan, M.D., director, The Male Clinic, Beverly Hills, CA., and an investigator in the studies.

Erectile dysfunction is defined as the inability to obtain and maintain an erection sufficient for intercourse.

The three studies were multicentre, double-blind studies where patients were randomised to four treatment arms of Uprima versus placebo -- 2 mg, 4 mg, 5 mg and 6 mg. The studies measured the number of attempts resulting in an erection firm enough for intercourse.

The first presentation consisted of data from a study that evaluated 520 male erectile dysfunction patients and found that the Uprima doses demonstrated a significantly higher percentage of attempts resulting in an erection firm enough for intercourse versus placebo (2 mg group -- 44 percent versus 38 percent; 4 mg group -- 58 percent versus 37 percent; 5 mg group -- 53 percent versus 29 percent and 6 mg group - 61 percent versus 29 percent; respectively).

The second presentation consisted of data from two studies and found similar results in hypertension patients. Hypertension is associated with erectile dysfunction. The study evaluated 977 patients, of which 236 were hypertensive and found that the Uprima doses also demonstrated a significantly higher percentage of attempts resulting in an erection firm enough for intercourse versus placebo (2 mg group -- 42 percent versus 32 percent; 4 mg group -- 51 percent versus 28 percent; 5 mg group -- 46 percent versus 30 percent; and 6 mg group -- 63 percent versus 33 percent; respectively).

The most common adverse event reported in these studies was nausea, mostly mild-to-moderate.

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