UPRIMA ®
apomorphine, co-marquetting avec Ixense ®
Voir ===> : Information complète en français (Juin 2001)
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.
References
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.