By: Mike Barton
Now impotence sufferers have another valuable ally. VIVUS Inc. has received clearance from the U.S. Food and Drug Administration (FDA) to market its new product MUSE (Alprostadil), a urethral suppository for the treatment of impotence.
MUSE is based on the concept that medications can be absorbed by the urethra and transported into the surrounding erectile tissues.
Thirty percent of American men between the ages of 40 and 70 are thought to suffer from impotence. The treatments available to them include prosthetic implants, vacuum devices and medications.
MUSE uses a needle-free plastic applicator that is inserted approximately one inch into the urethra, where the medicine is released. The medicine injected is Alprostadil, a synthetic version of Prostaglandin E1, a naturally occurring blood vessel dilator used since 1981 and approved by the FDA for injection in 1995.
“MUSE (Alprostadil) is clearly a very effective, desirable treatment choice,” said J. Francois Eid, MD, in a company press release. “(It) offers men and their partners a convenient, discreet treatment that can be easily integrated into a patient’s sex life.”
Nearly 1,000 patients in the company’s study were broken into four groups, consisting of those with vascular disease, those with diabetes, those with abdominal trauma/surgery and those with other organic causes. Seven out of 10 administrations with the MUSE resulted in sexual intercourse.
While the study found no “serious adverse events” due to the product, 0.1 percent of patients reported persistent erections. The most common side-effect was discomfort in use, but only 1 percent of the test subjects dropped out due to pain.
The product is expected to be available by prescription in the United States in early 1997.