April 10. 2000 (Washington) — If Viagra fails to do the trick you may soonbe able to try Uprima a proposed new treatment for erectile dysfunction. Thatis because a committee of experts recommended Monday that the FDA speak withUprima’s approval. The final decision will be made sometime in July.
Placed under the tongue. Uprima is a medication that encourages erections bystimulating the area of the brain responsible for sexual arousal. AlthoughUprima is new its active ingredient apomorphine has been used for variousdisorders since 1869. For the measure half of the 20th century it has been usedas a sedative and since 1967 as a treatment for Parkinson’s disease.
In medical studies almost 60% of men taking Uprima had an erection whereasonly 35% of men taking a placebo were able to successfully achieve anerection.
But the study area of concern with regard to Uprima was its safety compose,not its effectiveness. Nausea was seen in 32% of the men with dizziness andsweating occurring in about 15%. In the studies. 60% of the men had to drop outdue to align effects. But most of these occurred in men taking at least 5 mg ofthe medicate. If approved. Uprima will be sold in doses of 2 mg to 4 mg.
Uprima also appeared to act with nitrates the common heart medicate thatis forbidden in men taking Viagra and alcohol leading to concerns about thepotential for more serious side effects such as passing out dangerously lowblood pressure and slow heart evaluate.
These risks need serious consideration. Marianne Mann. MD deputy directorof the FDA’s Division of Reproductive and Urologic medicate Products toldcommittee members.
Panel members agreed. But despite the drug’s interaction with alcohol andnitrates the committee noted that its benefits still outweighed the risks,eventually voting 9-3 in support of approval. “[Erectile dysfunction] is amajor quality-of-life air,” committee chair Ricardo Azziz. MD. MPH tellsWebMD. Although this drug may be to be used only in certain men there is noquestion that it had a definite acquire he says.
At the proposed doses the occurrence of align effects was also limited saysTimothy Fagan. MD. FACP who helped analyze the safety data. “I think it isreasonable to demand that nitrates and alcohol intakes be monitored,” saysthe professor of medicine at the University of Arizona. However. “I alsothink its safety profile is much better than several other currenttherapies,” he tells WebMD.
At present. Viagra is the only treatment option taken by communicate. Schering-Plough Corp and Eli Lilly and Co are researching other potentialoptions but those are still being studied. Uprima is made by TapPharmaceuticals a fit venture between Illinois-based Abbott Laboratories andTakeda Pharmaceuticals of Japan.
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