New Study Demonstrates Long-Term Safety of VIVUS' MUSE; Data Presented Today at the American Urological Association
BusinessWire, Tuesday, June 02, 1998 at 07:48
MOUNTAIN VIEW, Calif.--(BW HealthWire)--June 2, 1998--With the
treatment of impotence becoming an everyday topic of discussion, talk
is now turning to a key aspect of treatment -- safety.
Data is being presented today at the American Urological
Association (AUA) meeting in San Diego on a large clinical trial
program of MUSE(R) (alprostadil), a treatment for erectile dysfunction
manufactured and distributed by VIVUS, Inc. (NASDAQ:VVUS).
Results released today of a large clinical trial program show
that MUSE(R) (alprostadil) demonstrated long-term safety (in excess of
24 months) with regard to drug-related and/or serious adverse effects.
MUSE was evaluated in 2,591 men with moderate to severe, organic
erectile dysfunction in trials throughout the United States and
Europe, and was shown to be well-tolerated with a favorable long-term
safety profile.
"This study confirms earlier findings that MUSE is a safe
product," said Dr. Richard F. Labasky, lead investigator of the study
and assistant professor of surgery at the University of Utah School of
Medicine in Salt Lake City, Utah. "What's noteworthy is we've been
able to follow patients who have been using MUSE for more than two
years and the safety profile has remained very consistent. This study
group included men after prostate surgery as well as those with severe
vascular disease and diabetes, which highlights the safety of this
drug in an organic dysfunction population."
MUSE has been used by more than 600,000 men in the United States
since January 1997. MUSE, the first and only transurethral delivery
system for erectile dysfunction, is based on the discovery that the
urethra can absorb certain medications. Because MUSE is administered
locally, it minimizes potential systemic side-effects and drug:drug
interactions.
In placebo-controlled trials of MUSE, hypotension, dizziness and
syncope occurred in 3%, 4% and 0.4%, respectively, of patients during
in-clinic titration, and alprostadil-related side effects with home
therapy included penile pain, occurring in approximately 30% of
patients. Treatment with MUSE resulted in a minimal serious adverse
event rate similar to treatment with placebo; MUSE did not increase
the incidence of heart attack, stroke, hospitalization, disability or
death.
"Significant clinical experience has been gathered using MUSE,"
said Dr. Labasky. "The drug is well-tolerated and has a favorable
long-term safety profile in patients with underlying organic
conditions undergoing therapy for erectile dysfunction."
In addition to the MUSE safety data released today at AUA, VIVUS
is presenting abstracts on two investigational therapies for erectile
dysfunction. One study discusses the efficacy of MUSE in conjunction
with the ACTIS(R) adjustable penile constriction band. The study,
which was led by Ronald W. Lewis, M.D., shows that the combination of
MUSE and ACTIS "may augment the drug effect (of MUSE alone) and is an
effective, non-invasive method to restore sexual function in the
majority of men with erectile dysfunction."
Another study focused on a new transurethral bi-mix, ALIBRA,
consisting of transurethral alprostadil and the alpha blocker
prazosin, shown in preliminary studies to be effective in men with
erectile dysfunction. This study, which was led by Raymond A.
Costabile, M.D., shows that the "combination of alprostadil/prazosin
resulted in successful sexual intercourse in a significant number of
men unresponsive to alprostadil alone."
VIVUS is completing clinical studies in support of regulatory
filings to obtain marketing clearance for ALIBRA, and the use of MUSE
in combination with ACTIS.
Founded in 1991, VIVUS, Inc. is a leader in the development of
advanced therapeutic systems for the treatment of erectile
dysfunction, commonly referred to as impotence. VIVUS has pioneered a
novel therapy for erectile dysfunction known as MUSE(R) (alprostadil).
This therapy consists of a proprietary, non-invasive drug delivery
system that delivers pharmacologic agents via the urethra.
Note to Editors: MUSE is a registered trademark of VIVUS, Inc.
Additional written materials, recent releases and Company information
are available through a variety of sources, including: the VIVUS home
page (www.vivus.com) and the VIVUS Fax-On-Demand Service
(1-888-329-5719) |
