New Drug for Male Impotence Backed by FDA Experts
April 10, 2000 (Washington) — If Viagra fails to do the trick, you may soon
be able to try Uprima, a proposed new treatment for erectile . That
is because a committee of experts recommended Monday that the FDA proceed with
Uprima’s approval. The final decision will be made sometime in July.
Placed under the tongue, Uprima is a medication that encourages erections by
stimulating the area of the brain responsible for sexual arousal. Although
Uprima is new, its active ingredient, apomorphine, has been used for various
disorders since 1869. For the last half of the 20th century, it has been used
as a sedative, and since 1967, as a treatment for Parkinson’s disease.
In medical studies, almost 60% of men taking Uprima had an erection, whereas
only 35% of men taking a placebo were able to successfully achieve an
erection.
But the major area of concern with regard to Uprima was its safety profile,
not its . Nausea was seen in 32% of the men, with dizziness and
sweating occurring in about 15%. In the studies, 60% of the men had to drop out
due to side effects. But most of these occurred in men taking at least 5 mg of
the drug. If approved, Uprima will be sold in doses of 2 mg to 4 mg.
Uprima also appeared to interact with nitrates, the common heart drug that
is forbidden in men taking Viagra, and alcohol, leading to concerns about the
potential for more serious side effects, such as passing out, dangerously low
blood pressure, and slow heart rate.
These risks need serious consideration, Marianne Mann, MD, deputy director
of the FDA’s Division of and Urologic Drug Products, told
committee members.
Panel members agreed. But despite the drug’s interaction with alcohol and
nitrates, the committee noted that its benefits still outweighed the risks,
eventually voting 9-3 in support of approval. “Erectile dysfunction is a
major quality-of-life issue,” committee chair Ricardo Azziz, MD, MPH, tells
WebMD. Although this drug may need to be used only in certain men, there is no
question that it had a definite benefit, he says.
At the proposed doses, the occurrence of side effects was also limited, says
Timothy Fagan, MD, FACP, who helped analyze the safety data. “I think it is
reasonable to require that nitrates and alcohol intakes be monitored,” says
the professor of medicine at the University of Arizona. However, “I also
think its safety profile is much better than several other current
therapies,” he tells WebMD.
At present, Viagra is the only treatment option taken by mouth.
Schering-Plough Corp. and Eli Lilly and Co. are researching other potential
options, but those are still being studied. Uprima is made by Tap
Pharmaceuticals, a joint venture between Illinois-based Abbott Laboratories and
Takeda Pharmaceuticals, of Japan.
Vital Information:
- An expert panel has recommended that the FDA approve Uprima, a new pill to
treat impotence. - The drug has a 60% success rate, compared to a 35% success rate for
placebo. - Side effects reported by patients taking Uprima included nausea, dizziness,
and sweating, and the drug may have interactions with nitrates and
alcohol.
, and more another.