Management responds and the negative study report stinks!!!!! If the authors claim "highest dose failed" and only 10% got 1000 mg they should be sued for liable!
Friday June 5, 7:31 am Eastern Time
Company Press Release
VIVUS Responds to Reports of "Disappointing Results"
With MUSE
MOUNTAIN VIEW, Calif.--(BW HealthWire)--June 5, 1998--VIVUS, Inc. (NASDAQ:VVUS -
news) 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 |
