Results From a Pivotal Clinical Study of VIVUS' Erectile Dysfunction Product Reported at Diabetes Meeting.

MENLO PARK, Calif.--(BUSINESS WIRE)--June 13, 1995--VIVUS Inc. (NASDAQ:VVUS) today reported that results from a pivotal phase II/III clinical study and the first of two follow-on home titration studies on the company's MUSE (Medicated Urethral System for Erection) product were presented today at the American Diabetes Association meeting in Atlanta.

Fran Kaiser, M.D., associate director of the division of geriatric medicine at St. Louis University School of Medicine, reported that more than 70% of men with long-standing erectile dysfunction experienced restoration of their erections resulting in sexual intercourse. This study evaluated the use of MUSE, a new non-invasive treatment for erectile dysfunction that combines an innovative drug-delivery system with established therapeutic agents.

In the phase II/III clinical study involving 234 patients, 76.5% of the men receiving active drug (alprostadil and prazosin HCI, alone and in combination) achieved an erection on at least one dose judged to be sufficient for sexual intercourse, compared to only 2.7% of those patients receiving placebo. In the home titration study involving 66 patients, results show that 71.2% of the men on active drug succeeded on at least one dose in having sexual intercourse, compared to only 12.3% of patients on placebo. "These findings demonstrate efficacy with high statistical significance," said Neil Gesundheit, M.D., VIVUS vice president of clinical and regulatory affairs.

The men in these studies had an average age of 60 and complete erectile dysfunction for at least 90 days. The average duration of erectile dysfunction was four years.

The MUSE consists of a small, single-use, disposable plastic applicator that contains the therapeutic agents. The end of the applicator, about 3.5 millimeters in diameter, is inserted about three centimeters (just over an inch) into the urethra, where the medication is released and absorbed through the urethral mucosa into the surrounding erectile tissues. An erectile response is produced within minutes of administration and lasts for about 30 to 60 minutes.

"The MUSE is discreet and takes less than a minute to administer, making it easy to integrate into an individual's sex life," said Dr. Gesundheit. "Because it mimics normal penile vasodilation, this method produces an erection that is more natural than those produced by other therapies."

Researchers noted the principal side effect of MUSE, reported by less than a third of the patients, is mild to moderate transient penile/perineal discomfort, attributable to the therapeutic agent. It was further reported that the discomfort, lasting about 15 minutes, generally was not sufficient to interfere with the men's goal of sexual intercourse.

The MUSE represents a new and advanced approach to treating erectile dysfunction, based on the discovery that the urethra, although an excretory duct, can absorb certain pharmacologic agents into the surrounding erectile tissues. "Intraurethral delivery constitutes a radical departure from all other therapies currently in use," said Leland F. Wilson, president and chief executive officer.

Wilson added, "this clinical data and data recently presented at the American Urological Association meeting supports the safety and efficacy of our first product, MUSE-alprostadil. We expect to continue to make our milestones throughout 1995 culminating in the filing of a New Drug Application in 1996 for MUSE-alprostadil."

VIVUS Inc. is a leader in the development of advanced therapeutic systems for the treatment of erectile dysfunction, commonly referred to as impotence. The anticipated first product, MUSE-alprostadil, is currently in Phase III clinical studies.

CONTACT: VIVUS Inc.

Barbara Clark (IR) or David Yntema (CFO), 415/325-5511