MOUNTAIN VIEW, Calif., May 17, 2011 /PRNewswire/ — VIVUS,
Inc. (NASDAQ:
VVUS) today announced that positive results from a pivotal
phase 3 open-label clinical trial evaluating long-term safety and
efficacy of the investigational drug avanafil for the treatment of
erectile dysfunction (ED) were presented at the 2011 Annual Meeting
of the American Urological Association in Washington, D.C.
Laurence Belkoff, DO, FACOS, Chairman of the Department of
Specialty Surgeries and the Division of Urology at the Philadelphia
College of Osteopathic Medicine presented the results during the
late-breaking science forum. The top-line results had been
previously reported; however, the presentation by Dr. Belkoff marks
the first time these results have been presented at a major medical
meeting.
The study met all primary endpoints by demonstrating sustained
improvement from baseline in erectile function as measured by the
Sexual Encounter Profile (both SEP 2 and SEP 3) and improvements in
the International Index of Erectile Function (IIEF). The
study also indicated that successful intercourse (as measured by
SEP 3) was achieved as early as 15 minutes, consistent with results
from previously reported phase 3 double-blind, placebo-controlled
studies.
“The avanafil data from the open label, long-term safety study
confirm the safety and efficacy results previously observed
in the two placebo-controlled trials,” commented Dr.
Belkoff. “The safety profile demonstrated during the
year-long study and successful intercourse attempts within 15
minutes of dosing suggest avanafil, if approved, may
be an attractive treatment option for men with ED.”
Highlights of the TA-314 study include:
Eighty percent (80%) of sexual attempts among patients on avanafil
resulted in erections sufficient for intercourse (SEP 2)
Erectil
‘/>”/>
SOURCE