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 dysfunction. 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 effectiveness. 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 Reproductive 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.
- 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.