UNIVERSITY DAILY KANSAN
Monday, May 6,1996
9A
Impotence medication test results offer hope
The Associated Press
WASHINGTON — A pill that restores full function to impotent men now is in the final phases of clinical testing and could be available in the United States late next year, a British scientist says.
The drug, called sildenafil, works by blocking the action of an enzyme in the penis that tends to aggravate impotence, said Iain Osterloh, a researcher with Pfizer Inc. in Britain.
"The pill is taken an hour or so before it is needed," said Osterloh. "It will do nothing, however, in the
absence of sexual stimulation."
Reports on clinical studies of the drug will be given today at a meeting of the American Urological Association in Orlando. Fla.
In one study, 42 patients who had been impotent for at least three years were divided into two groups, with one group taking the pill and the other taking a placebo. None of the patients knew which they were taking. Later, the two groups
switched. After 28 days, 92 percent of the men reported significantly improved performance while they were on the pill.
A study using 351 patients with an average age of 63 randomly assigned patients to take one of three doses the pill or a placebo.
After 28 days, 89 percent of the men on a 50-milligram dose reported a threefold improvement in their abilities. Interestingly, 38 percent of those on placebo also reported improvement.
Osterloh said the effect of the drug was gauged with a questionnaire
filled out by the patients and another form filled out by their partners.
"This drug may be very important for treating a condition that can cause a lot of distress for many people," Osterloh said. Impotence affects about 10 percent of all adult men.
The drug now is in its third trial phase in both the United States and Europe, and Osterloh said his company planned to apply to the Food and Drug Administration for marketing approval in late 1997.
So far, the side effects of the drug have been minor for most patients,
he said, and still are being tested. They have included headaches, muscle soreness and stomach upset.
Osterloh said that researchers had found sildenfil while trying to develop a heart drug.
It failed as a heart drug, Osterloh said, but patients testing the compound found that it tended to solve their impotence problems.
"After we learned that, we switched to impotence research," he said.
The company plans to market sildenfil under the brand name Viagra.
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