ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Monday, May 6, 1996 TAG: 9605060098
SECTION: NATIONAL/INTERNATIONAL PAGE: A-2 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: Associated Press
A pill that restores full function to impotent men is now in the final phases of clinical testing and could be offered for sale in the United States late next year, a British scientist says.
The drug, called sildenfil, works by blocking the action of an enzyme in the penis that tends to aggravate impotence, said Dr. Ian 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 Monday at a meeting in Orlando, Fla., of the American Urological Association.
Osterloh said that in studies of hundreds of patients in Europe, the drug helped many men perform who had been impotent for years.
In one study, 42 patients, all with impotence for at least three years, were divided into two groups, with half taking the pill and half taking a placebo. None of the patients knew which they were taking. Later, the two halves switched sides. After 28 days, 92 percent of the men reported significantly improved performance during the days they were on the pill.
A larger study, using 351 patients, with an average age of 53, randomly assigned patients to take the pill, at one of three doses, or a placebo.
After 28 days, 89 percent of the men on 50-milligram pills 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 the partners of the patients.
``This drug may be very important for treating a condition that can cause a lot of distress for many people,'' said Osterloh. He said impotence affects about 10 percent of all adult men.
The drug is now in Phase III trials in both the United States and Europe. Osterloh's company plans to apply to the Food and Drug Administration for marketing approval late in 1997.
So far, the drug's side effects have been minor for most patients, he said, but that is still being tested. The side effects, said Osterloh, have included headaches, muscle soreness and stomach upset.
Researchers found sildenfil, he said, while researching a heart drug.
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