Move Over, Viagra; There’s a New (Maybe Better) Drug in Town
Two years after Viagra made its stunning debut--transforming the sex lives of millions and generating a glut of office-cooler jokes--a second pill for impotence is waiting in the wings.
The new pill, called Uprima, is considered a worthy rival to the hugely successful Viagra, which has sold 20 million prescriptions. Studies show that Uprima works much faster than Viagra.
In clinical trials of more than 2,500 men, Uprima users were able to obtain an erection in about 15 to 20 minutes; as soon as 10 minutes for some men.
Viagra is said to work about an hour after it is taken, although the response is faster in some men.
The big advantage of Uprima is that it will help “restore spontaneity to a couple’s sex life,” says Dr. Eugene Dula, medical director of West Coast Clinical Research in Van Nuys and an investigator in the clinical trials.
It is expected that the U.S. Food and Drug Administration will approve Uprima, made by TAP Pharmaceuticals of Deerfield, Ill., by July 1. An FDA advisory committee voted 9-3 in April to recommend approval.
Uprima is the first oral medication to follow Viagra, and it surely will not be the last. Several drug companies--including German drug giant Bayer and Zonagen Inc. of The Woodlands, Texas--are testing drugs for impotence. The disorder, also known as erectile dysfunction, is thought to affect as many as 30 million U.S. men.
Doctors are particularly interested in Uprima because it represents a new class of impotence medications. While Viagra acts peripherally, by increasing blood flow to the penis, Uprima acts on the brain to ignite sexual responsiveness.
Uprima “has a unique mechanism of action,” Dula says. “This drug works centrally on the brain and stimulates that part of the brain that sends a message to the penis.”
Uprima is a pill that is placed under the tongue, where it dissolves and moves into the bloodstream faster than a medication, like Viagra, that is swallowed. And, unlike Viagra, food does not interfere with the drug. Men are advised to wait an hour after eating before taking Viagra.
Uprima may also benefit the estimated 40% of impotent men who are not helped by Viagra.
But Uprima can have side effects, such as nausea, vomiting or fainting.
The FDA panel that recommended approval of Uprima included “many caveats for safety,” according to Susan Cruzan, an FDA spokeswoman.
Uprima’s biggest drawback is that it causes mild to moderate nausea in about 17% of men; and vomiting, fainting, sleepiness and dizziness in smaller numbers.
The nausea, however, appears to be a temporary side effect that goes away after about the third dose, says Dr. John Mulhall, a urologist at Loyola University Medical Center in Chicago, who has studied Uprima.
Uprima can also cause a drop in blood pressure among men using nitrates, a medication to control angina. The drug was tested, and appears to be safe, for men with a variety of health problems, including heart disease, hypertension and diabetes.
Concerns over Viagra’s safety were heightened in November 1998, when the FDA required the drug to carry new health warnings that cautioned men with heart problems or very low blood pressure to be carefully examined before obtaining a prescription.
The FDA, however, declined to link the 130 reported deaths to the drug, explaining that the deaths were mostly among men older than age 64 who had serious health problems that were aggravated by sexual activity, resulting in heart attack or stroke.
There are many urologists nationwide who believe that Viagra is also probably safe for most men--even those with heart disease.
A study published last week in the New England Journal of Medicine examined the cardiac response of men with existing heart disease--but who were stable and on medications other than nitrates--before and after taking Viagra. The drug had no adverse effects on cardiac function, researchers from the University of Pennsylvania Medical Center reported.
But, they said, the study did not address the added risk of exertion from sexual activity or how men with unstable symptoms of heart disease might react to the drug.
“There is no data to show Viagra causes a problem in an appropriately selected patient,” Mulhall says.
Even if Viagra has gotten a bad rap for being linked to cardiac deaths, some men may opt for a newer drug that carries less baggage, Dula says.
“There are a lot of men who aren’t being treated for impotence,” he says. “They are afraid to take Viagra because of the bad press it has received; men without any risk factors who are just afraid of it. I think [Uprima] will help alleviate that concern.”
Many doctors think that both medications may play a role in treating impotence, since each acts differently in the body. A study set to begin this year will test how the drugs work when taken in combination. But, for now, men should try one drug at a time.
“I think combination therapy will be the way of the future,” Mulhall says. “But before any two therapies are combined, you need safety data.”
