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New way of giving impotence drug avoids injections
Web posted January 2, 1997
The new method, which involves inserting a tiny drug-carrying pellet into the urethra, was approved by the U.S. Food and Drug Administration a few weeks ago and is expected to be on the market later this month.
``This is the first noninjectable drug delivery system for the treatment of impotence that is both safe and effective,'' said Dr. Harin Padma-Nathan.
Dr. Padma-Nathan, who runs the Male Clinic in Santa Monica, Calif., and is on the faculty at the University of Southern California, directed a study of the new method on men who had been unable to have erections for an average of four years.
The treatment is a medicine known as alprostadil, a synthetic form of the hormone prostaglandin E. It relaxes smooth muscle in the penis, allowing blood to flow in and cause an erection. It has been available for about two years but must be injected into the penis.
In the new approach, a slender plunger is pushed 1« inches into the end of the penis to insert the tiny medicated pellet.
Doctors tested the medicine on 1,511 impotent men who ranged in age from 27 to 88. When the medicine was given in the clinic, 961 of these men were able to achieve erections and agreed to further testing. They were randomly given either the real medicine or dummy pellets to use at home.
Sixty-five percent of the men getting the genuine treatment were able to have intercourse, compared with 19 percent in the comparison group.
The men typically got erections within five minutes, and they lasted about an hour.
The most common side effect was a dull ache in the penis, which occurred in 11 percent of the treatments. Doctors said the pain was caused by the medicine itself, not its administration, and only rarely did men refuse to continue the study because of it.
The new method of administering the drug was developed by Vivus Inc., of Menlo Park, Calif., which partially paid for the study.
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