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VIVUS
Announces Results Of ALISTA Phase 2b Study
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Main Category:
Women's Health / OBGYN News
Article Date: 30 Sep 2006 - 0:00am (PDT)
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VIVUS, Inc. (Nasdaq: VVUS), today announced results of
the company's Phase 2b clinical study of its
investigational drug ALISTA(TM) (topical alprostadil),
for the treatment of female sexual arousal disorder (FSAD),
in women who have undergone a hysterectomy. In this
double-blind, placebo-controlled study, patients with
FSAD using ALISTA achieved a more than doubling over
baseline in the number of satisfactory sexual events;
however, the difference between the ALISTA treatment
group and the placebo group did not achieve statistical
significance for the primary endpoint of the study.
Following a 2-month non-treatment run-in period, 320
subjects were randomly assigned to treatment with ALISTA
or placebo for a period of 6 months. During study
participation, subjects maintained daily diaries to
capture outcomes of all sexual encounters, and the
primary measure of treatment efficacy was based on the
difference between ALISTA and placebo in the improvement
over baseline in the number of satisfactory sexual
encounters per month. This was the first study in which
the efficacy of ALISTA was prospectively evaluated in an
all organically impaired group of patients with FSAD.
"The placebo response rate was higher than what was
anticipated in this phase 2b trial," said Leland Wilson,
president and CEO of VIVUS.
"Additional work will be required to determine how to
better control the placebo response rate in this patient
population before additional clinical trials can be
started. Because we have a rich pipeline with three
late-stage development programs, ALISTA will receive a
lower development priority at VIVUS. We will focus our
development efforts on Qnexa for the treatment of
obesity, Testosterone MDTS for the treatment of
hypoactive sexual desire disorder (HSDD) and avanafil
for the treatment of male erectile dysfunction (MED),
all of which have demonstrated clear, clinical and
statistical significance over placebo in phase 2
studies."
About VIVUS
VIVUS, Inc. is a pharmaceutical company dedicated to the
development and commercialization of next-generation
therapeutic products addressing obesity and sexual
health. VIVUS has three products that are positioned to
enter Phase 3 clinical trials, and one product that has
completed Phase 3 evaluation, for which an NDA is
anticipated to be submitted to the U.S. Food and Drug
Administration (FDA) in the second half of 2006. The
investigational pipeline includes: Qnexa(TM), for which
a Phase 2 study has been completed for the treatment of
obesity; Testosterone MDTS(R), for which a Phase 2 study
has been completed for the treatment of Hypoactive
Sexual Desire Disorder (HSDD); Evamist(TM), for which a
Phase 3 study has been completed for the treatment of
menopausal symptoms; avanafil, for which a Phase 2 study
has been completed for the treatment of erectile
dysfunction (ED); and, MUSE(R), which is approved and
currently on the market for the treatment of ED. For
more information on clinical trials and products, please
visit the company's web site at
http://www.vivus.com.
Certain statements in this press release are
forward-looking within the meaning of the Private
Securities Litigation Reform Act of 1995. These
statements may be identified by the use of
forward-looking words such as "anticipate," "believe,"
"forecast," "estimated" and "intend," among others.
These forward-looking statements are based on VIVUS'
current expectations and actual results could differ
materially. There are a number of factors that could
cause actual events to differ materially from those
indicated by such forward-looking statements. These
factors include, but are not limited to, substantial
competition; uncertainties of patent protection and
litigation; uncertainties of government or third party
payer reimbursement; reliance on sole source suppliers;
limited sales and marketing efforts and dependence upon
third parties; risks related to the development of
innovative products; and risks related to failure to
obtain FDA clearances or approvals and noncompliance
with FDA regulations. As with any pharmaceutical under
development, there are significant risks in the
development, regulatory approval and commercialization
of new products. There are no guarantees that future
clinical studies discussed in this press release will be
completed or successful or that any product will receive
regulatory approval for any indication or prove to be
commercially successful. VIVUS does not undertake an
obligation to update or revise any forward-looking
statement. Investors should read the risk factors set
forth in VIVUS' Form 10-K for the year ended December
31, 2005 and periodic reports filed with the Securities
and Exchange Commission.
VIVUS, Inc
http://www.vivus.com
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