FRIDAY, Dec. 13, 2002 (HealthDayNews) -- A drug maker is once again seeking U.S. Food and Drug Administration (FDA) approval for a new kind of erection pill.
Uprima, whose original application to the FDA was pulled in 2000 after concerns were raised that it caused fainting spells, has been further studied in lower dosages, says its manufacturer, TAP Pharmaceuticals. The company withdrew its original application under pressure, even though a key FDA advisory panel recommended its approval.
"We've completed several new studies to evaluate the safety and efficacy of Uprima at two and three milligrams, and we feel we have provided the FDA with the best new drug application for Uprima," says Kim Modory, a spokeswoman for the drug company, located in Lake Forest, Ill. The new application was submitted in October. Uprima has already been approved and is available in Europe.
Uprima is a drug that acts on dopamine, a brain chemical central to sexual arousal. It is taken in pill form, and dissolved under the tongue, producing an erection in 20 minutes, says Dr. John Mulhall, a urologist at Weill Medical College of Cornell University and New York Presbyterian Hospital in New York City. He has run several of the clinical trials of the drug, studies that included doses as high as six milligrams as well as the new ones with the lower doses.
Uprima behaves differently from Viagra, Pfizer's blockbuster erection drug, which acts by increasing the blood flow to the penis.
Public Citizen's Health Research Group, a consumer advocacy organization, raised the concerns about Uprima. The group pointed out that the drug, which helped about 60 percent of the men who took it, can cause a sudden drop in blood pressure, and that men who take it could faint, which could cause injury. Also of concern was that the studies did not include populations with health problems for whom Uprima might be dangerous, but who might take the drug anyway if it were available.
Modory says that those concerns have been addressed in the new studies.
"Using doses of two and three milligrams, we did provide additional information on syncope [fainting], on cardiovascular safety, alcohol and interaction with antidepressants," Modory says.
Dr. Robert Feldman, medical director of a research center on erectile dysfunction, has been following the development of Uprima and isn't sure how effective a drug it will be.
"They've done very good studies with this, and reduced the dosage, but I just don't know where it's going to fit in," he says.
Because of the worry about fainting, he says, he would be leery about giving it to elderly patients, but says there are other groups for whom it would be a good choice.
"It's supposed to be pretty effective among those with diabetes, and I would use it for those men who can't take Viagra," he says. "There is also a third group of men who want a quick response." Viagra can take up to an hour to produce an erection, Feldman says.
He adds, though, that Uprima represents new thinking in treating erectile dysfunction.
"There is more we're going to learn about the brain being responsible for erections, and we're going to see more of this in the future," Feldman says, "This drug is just the first one out."
About 5 percent of 40-year-old men and between 15 percent and 25 percent of 65-year-old men experience erectile dysfunction, according to the National Kidney and Urologic Diseases Information Clearinghouse (NIDDK), and estimates of those suffering from the malfunction range from 15 million to 30 million American men.
Treatments have included reviewing and changing medications that men take, diet, psychotherapy and -- most recently -- the drug Viagra, which increases blood flow to the penis and improves the response to sexual stimulation.
What To Do
For more information on erectile dysfunction, you can visit the National Kidney and Urologic Diseases Information Clearinghouse. Another source of information is the Endocrine Society.
