VIVUS Begins Phase II Study With ALISTA For The Treatment of Female
Sexual Dysfunction
MOUNTAIN VIEW, Calif.--Jan. 23, 2001--VIVUS, Inc. (Nasdaq NM:VVUS)
today announced enrollment of patients in a Phase II study to evaluate
the safety and efficacy of the Company's female sexual dysfunction
(FSD) product, ALISTA(TM). This multi-center, double-blind,
placebo-controlled study is intended to evaluate the sexual response
with ALISTA in women with a primary diagnosis of Female Sexual Arousal
Disorder (FSAD).
"This is an exciting time for VIVUS as we progress to the next
phase of clinical development for our lead product intended to treat
women with FSAD," said Leland F. Wilson, President and CEO. "Results
from this study will provide preliminary data on the efficacy of
ALISTA in a population of women with FSAD, and will help us to design
the larger pivotal studies that will be required for global regulatory
submissions."
Researchers have classified the range of symptoms seen in FSD into
four subcategories: desire, arousal, orgasmic and sexual pain
disorders. The VIVUS clinical program is designed to evaluate ALISTA
in women with a primary complaint of arousal disorder.
ALISTA is a proprietary formulation of alprostadil applied locally
to the female genitalia. Alprostadil is a synthetic version of a
naturally occurring vasodilating agent. It is the same active
ingredient found in the VIVUS product MUSE(R), which is used to treat
male erectile dysfunction. ALISTA is believed to increase blood flow
to the female genitalia, thereby promoting engorgement and other
natural processes that occur during sexual stimulation. With both
issued and pending patents, the Company believes it has the dominant
patent position for the local delivery of prostaglandins, such as
alprostadil, in the treatment of women with FSD.
VIVUS, Inc. is a specialty pharmaceutical company engaged in the
development of innovative therapies for the treatment of
quality-of-life disorders in men and women, with a focus on sexual
dysfunction. The Company developed and markets in the U.S. MUSE(R)
(alprostadil) and ACTIS(R) (recently cleared for OTC marketing), two
innovations in the treatment of erectile dysfunction, and has
partnered with Abbott Laboratories (NYSE: ABT) for the international
marketing and distribution of its male transurethral ED products. In
Canada, VIVUS has partnered exclusively with Paladin Labs to market
and distribute MUSE . VIVUS initiated clinical studies for its female
sexual dysfunction product, ALISTA(TM), during the fourth quarter of
2000.
Note to editors and investors: 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).
This news release contains forward-looking statements that involve
risks and uncertainties regarding VIVUS Inc.'s operations and future
results. Please see the Company's filings with the Securities and
Exchange Commission including, without limitation, the Company's Form
10-K and Form 10-Qs, which identify specific factors that may cause
actual results or events to differ materially from those described in
the forward-looking statements.
CONTACT: VIVUS, Inc.
Dick Walliser
650/934-5264
ir@vivus.com
www.vivus.com
or
INVESTOR CONTACTS:
Lippert/Heilshorn & Associates, Inc.
Bruce Voss (bruce@lhai.com)
Bonnie Feldman (bonnie@lhai.com)
310/691-7100
Media Contact
Pamela Rigler (pamela@lhai.com)
Carrie Kocik (carrie@lhai.com)
212/838-3777
www.lhai.com
FOR UP TO DATE INFORMATION ON VIVUS, SEE THE VIVUS INVESTOR SITE. GET THE LATEST FACTS, OPINIONS, AND COMPETITIVE INFORMATION YOU NEED. vivusinvestor.net
Interesting article regarding FSD: Vivus well represented.
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