FDA Approves First Impotence Pill
By LAURAN NEERGAARD
.c The Associated Press
WASHINGTON (AP) - The government approved the first pill to treat impotence today, a therapy long-awaited by millions of men because it promises to restore sexual function without making them wince.
Pfizer Inc.'s Viagra becomes the first nonsurgical impotence treatment that doesn't have to be either injected or inserted directly into the penis - and unlike those treatments, it doesn't cause erections unless the man is sexually stimulated.
Between 10 million and 20 million men suffer impotence at some point in their lives, and an oral therapy has been so eagerly anticipated that analysts estimate Viagra's sales could reach $500 million by 2003.
The pill, approved today by the Food and Drug Administration, will be available only by prescription.
The FDA said Viagra, known chemically as sildenafil, appeared to cause few side effects.
It works by blocking an enzyme found mainly in the penis. That enzyme is responsible for quelling an erection after sex by breaking down a chemical called cyclic GMP that is produced during sexual stimulation. The longer cyclic GMP stays around, the better chance a man has of an erection - hence Viagra's effect.
Impotence is highly treatable, but until today the options all had drawbacks. Penile implants require surgery. Vacuum-style devices used during sex, including one that FDA just designated the first over-the-counter impotence remedy, force blood into the penis but interrupt lovemaking. Injecting drugs into the penis can be painful and sometimes causes hours-long erections. Men are squeamish about the suppository Muse, a tiny medicated pellet that is pushed into the end of the penis with a slender plunger.
In studies of several thousand men, researchers reported that Viagra helped over 70 percent improve their erections.
Headaches and upset stomach appeared to be the main side effects, although a few men given higher doses had a strange reaction: temporary vision disturbance that left them unable to distinguish between the colors blue and green.
AP-NY-03-27-98 1110EST |
