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 vivus.
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
vivus
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