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TAP Holdings, a joint venture between Takeda Chemical Industries (Japan) and Abbott Laboratories (U.S.), will apply for FDA approval of Uprima (apomorphine) in mid-1999.
Uprima works in a different manner than Pfizer’s Viagra and will become the second class of oral medications available to impotent men. In the future, Viagra and Uprima may be used together to improve efficacy.
Three phase III studies were recently presented at the American Urological Association meeting in Dallas, Texas on May 4, 1999. It is anticipated that TAP will utilize these three studies in support of their New Drug Application in mid-1999.
How It Works
Uprima is a dopamine receptor agonist that acts on the central nervous system. Once absorbed and transported into the brain, Uprima initiates a chain of reactions that result in increased blood flow to the male genital organs and an erection.
Clinical Study Results
In multicenter, double-blind studies, patients were randomized to one of four treatment arms of Uprima (2 mg, 4 mg, 5 mg, 6 mg) versus placebo. The main outcome measure was the number of attempts resulting in an erection firm enough for intercourse.
The first study enrolled 520 male erectile dysfunction patients. Results indicated that patients who were randomized to Uprima demonstrated a significantly higher percentage of attempts resulting in an erection firm enough for intercourse versus placebo.
Two studies included hypertensive patients and showed similar results among this subpopulation. This is important because erectile dysfunction is often associated with hypertension. Among the 977 patients evaluated in the studies, of which 236 had high blood pressure, it was found that those using Uprima demonstrated a significantly higher percentage of attempts resulting in an erection firm enough for intercourse versus placebo.
In all studies, the patients who received the highest dose of Uprima (6 mg) had an approximate 60% effect compared to the 30% effect for those who received placebo.
What The Patient Should Know
Reported side effects of Uprima include nausea that is primarily mild-to-moderate.
1.Abbott Laboratories. Press Release, Abbott Laboratories 1999 May 4.
2.Meinhardt W, Kropman RF, Vermeij P. Comparative tolerability and efficacy of treatments for impotence. Drug Saf. 1999 Feb;20(2):133-46.