Novel impotence remedy; no shots, surgery or pumps; painless drug application leads to successful intercourse for 70% of men with long-standing erectile dysfunction

Business Wire, June 13, 1995

ATLANTA--(BUSINESS WIRE)--June 13, 1995--An exciting new non-surgical option to remedy impotence, even in older men with erectile dysfunction of many years duration, was reported here today at the American Diabetes Association's 55th Annual Scientific Sessions.

"This is the first report of successful use of a transurethral drug delivery system yielding not only restoration of erections but also sexual intercourse in more than 70% of men with long-standing erectile dysfunction caused by a wide variety of problems, including diabetes," reported Fran Kaiser, MD, associate director of the division of geriatric medicine at the St. Louis University School of Medicine. "Sex should be forever, so it's great to have a new safe and effective non-surgical intervention to treat this problem."

The study evaluated the benefits of drugs already in long use in cardiac care but delivered in a new way with a Medicated Urethral System for Erection -- called MUSE. It is a tiny plunger device, about an eighth of an inch in diameter at its tip, that a man briefly inserts into the urethral opening of the penis to dispense a minuscule pellet of medication, which is then absorbed through the mucous membranes lining the urethra.

Impotence -- now generally called erectile dysfunction by the urological community -- is the inability to develop and maintain an erection sufficient for intercourse. It is a common problem among men of all ages, especially those with diabetes or atherosclerosis, those who have had prostate surgery and those who take certain antihypertensive or antidepressant drugs.

Dimensions of the Problem

"More than 50% of men in the general population between ages 40 and 70 have some degree of erectile dysfunction, and the total rises to about 70% by the age of 70," explained Dr. Kaiser. More than 90% of erectile dysfunction is now known to be physiological, not psychological in origin. "Among men with diabetes, more than half experience impotence within 10 years of diagnosis, some as young as in their 20s, and 95% of men with diabetes over age 70 suffer with the problem."

Nearly 14 million Americans have diabetes, a serious disease that affects the body's ability to produce or properly respond to insulin, a hormone that allows blood sugar to enter the cells of the body and be used for energy. Diabetes can lead to severely debilitating or fatal complications, such as blindness, kidney disease, heart disease and amputations. It is the fourth-leading cause of death by disease in the U.S.

Men with diabetes may experience erectile dysfunction due to: accelerated arteriosclerosis of arteries supplying blood to and within the penis; damage to nerves leading to and within the penis; some drugs taken to treat complications of diabetes, such as hypertension; and other factors under study.

"It is important for men with diabetes who have erectile dysfunction to realize that there are options for treatment -- that they do not have to accept it as a hopeless complication of diabetes," said Kaiser. However, most men have been hesitant to try the treatment options now commonly available; surgery to implant prosthetic devices in the penis, painful penile injection therapy and awkward vacuum devices.

Less than 10% of all men with erectile dysfunction now receive treatment.

The MUSE Study

Vivus, Inc., a small Menlo Park, Calif., pharmaceutical firm, developed the MUSE, which was recently evaluated in a double-blind, placebo-controlled, multicenter clinical trial involving 234 men, average age 60, who had not achieved erection suitable for intercourse for an average of four years. The delivery system was tried with six different doses of alprostadil and/or prazosin -- drugs that relax smooth muscle and dilate blood vessels -- and placebo. Both drugs are FDA approved for cardiovascular-related problems, and alprostadil also is used for achieving erection with penile injections.

With an active drug inserted, erection began within five to 10 minutes and lasted 30 to 60 minutes, and 71.2% of the men succeeded in having intercourse, compared to only 12.3% on placebo.

Subjective evaluations were based on an erection assessment scale of: 1 -- no response; 2 -- some enlargement; 3 -- full enlargement; 4 -- erection sufficient for intercourse; 5 -- rigid. In the clinic, 76.5% of men receiving an active drug achieved levels 3, 4, or 5, compared to only 2.7% of those receiving placebo.

"Evaluation of the efficacy of MUSE was based not only on patient reports but on objective measurements of penile volume -- by measuring the circumference and length of the penis -- and buckling pressure -- a measure of penile rigidity when pressed against a gauge," explained Neil Gesundheit, MD, vice president of clinical and regulatory affairs at Vivus. "Results of the objective measures were almost identical to the patients' subjective rating scales."

The response in men with diabetes, both in the clinic and at home, was slightly better than that of men with other causes of erectile dysfunction.