VIVUS Responds to Reports of "Disappointing Results" With MUSE
Business Wire - June 05, 1998 07:46
%VIVUS VVUS %CALIFORNIA %MEDICINE %PHARMACEUTICAL %PRODUCT V%BW P%BW
MOUNTAIN VIEW, Calif.--(BW HealthWire)--June 5, 1998--VIVUS, Inc. (NASDAQ:VVUS) today responded to media
reports about "disappointing results" data presented at the American Urological Association (AUA) annual meeting earlier this
week in San Diego, CA. VIVUS would like to refer patients and physicians to the efficacy data of MUSE(R)(alprostadil)
amassed from 71 worldwide clinical trial sites and involving nearly 1,800 patients. Additional new data on the efficacy of
MUSE in clinical practice are scheduled for presentation at the American Diabetes Association meeting to be held June 13-16
in Chicago, IL.
The abstract presented at the AUA by researchers from Presbyterian Hospital in Dallas, TX stated that "only 27% of patients
achieved rigidity sufficient for intercourse despite being challenged to the highest dose." In discussing his study results, the
presenting physician clarified that not all men were challenged to the highest doses (500 or 1000 mcg) of MUSE, and that only
10 of these 115 patients (or 9%) were administered the 1000 mcg dose. In VIVUS' clinical trials of MUSE, between 41% and
65% of men required the 1000 mcg dose to achieve rigidity sufficient for intercourse.
The efficacy of MUSE was established in part through the VIVUS Phase III clinical study which was the basis of Food and
Drug Administration (FDA) approval of MUSE in November 1996. This 58-site U.S. study reported in the New England
Journal of Medicine in January 1997 found that 66% (996/1511) of men with severe, organic erectile dysfunction were able to
achieve an erection sufficient for intercourse in a clinic setting. A more recent 13-site study of MUSE conducted in five
European countries and reported in this month's issue of the British Journal of Urology found that 64% (159/249) of men with
severe, organic erectile dysfunction achieved an erection sufficient for intercourse in a clinic setting. Patients in these two
VIVUS-sponsored clinical studies received doses of MUSE up to and including the highest (1000 mcg) dose. Currently, over
80% of all prescriptions for MUSE are at the 500 or 1000 mcg dose level.
"Efficacy of MUSE is clearly dose dependent," said Tom Lue, MD, Professor of Urology, University of California, San
Francisco. "In my clinical practice, most patients require dosing of MUSE at the 500 or 1000 mcg level."
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). MUSE is a therapy which consists of a proprietary, non-invasive drug delivery system applied into the
urinary opening, and is not for men with sickle cell trait, disease or other blood disorders. One third of men reported genital
pain, causing some to stop use. A few men reported dizziness and, rarely, fainting.
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).
CONTACT: VIVUS
Nina W. Ferrari or David Yntema, 650/934-5200 |
