Vivus, Inc.: VVUS (NASDAQ)
Positive Data on ALISTA, VIVUS' Treatment for
Female Sexual Dysfunction, Presented at
the American Urological Association Annual Meeting
MOUNTAIN VIEW, Calif.-May 28, 2002--VIVUS, Inc. (Nasdaq: VVUS), a
developer of innovative pharmaceutical products to improve quality of
life, presented detailed results from an in-clinic evaluation of
ALISTA(TM), its topical product to treat Female Sexual Arousal
Disorder (FSAD), at the Annual Meeting of the American Urological
Association in Orlando, Florida. The results of this study
demonstrated that ALISTA significantly increased the patients' sexual
arousal, satisfaction with their level of sexual arousal, and their
overall level of sexual satisfaction.
Dr. Marc Gittelman, one of the investigators in the study and lead
author on the abstract, commented, "To our knowledge, this is the
first well controlled clinical trial to demonstrate that a locally
applied medical treatment can produce a significant improvement in
sexual arousal and satisfaction in women with FSAD."
In the study, 79 women suffering from FSAD were treated once with
placebo and once with ALISTA, either a 100 or a 400 microgram dose, in
association with visual sexual stimulation. Both doses of ALISTA
produced a highly significant (p less than 0.0001) increase in genital
vasocongestion (blood flow and engorgement). Additionally, the 400
microgram dose induced a rapid, long-lasting effect on various aspects
of the sexual response, in some cases occurring as early as five
minutes after application and lasting for up to 120 minutes. Compared
to placebo, the 400 microgram dose of ALISTA resulted in a 77%
increase in genital warmth and tingling (p less than 0.002), a 49%
increase in sexual arousal (p less than 0.017), a 57% increase in
satisfaction with sexual arousal (p less than 0.015), and a 97%
increase in sexual satisfaction (p less than 0.021). ALISTA was well
tolerated, both locally and systemically, by all patients.
This Phase II trial for ALISTA provides the first clear evidence
that women can respond positively to a medication intended to improve
sexual health. Confirmation that a drug can safely increase both
physical signs of sexual arousal, such as increased genital
vasocongestion, as well as other manifestations of sexual well-being,
such as increased sexual satisfaction as verified by the patients,
establishes an important milestone in women's health, particularly as
the Journal of The American Medical Association has reported as many
as 43% of women aged 18 to 59 experience some form of sexual
dysfunction.
"Based on these results, we entered the pivotal phase of
development for ALISTA with the initiation of our multi-center,
at-home Phase II/III trial in March 2002," said John Dietrich, Vice
President of Research and Development at VIVUS. "We are pleased that
patient enrollment continues on schedule and expect completion of this
study by year end. ALISTA is an on-demand medication that is applied
topically to the female genitalia. If confirmed in clinical trials, we
believe this treatment modality could have significant safety
advantages due to minimal systemic side effects and interaction with
other medications. Substantiation of the efficacy and safety of ALISTA
in current and future studies could provide a significant medical
advantage in the treatment of this condition," added Dr. Dietrich.
VIVUS, Inc. is a 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. Current
development programs target Female Sexual Dysfunction (FSD), Erectile
Dysfunction (ED) and Premature Ejaculation (PE). The Company developed
and markets in the U.S. MUSE(R) (alprostadil) and ACTIS(R), 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 (TSE: PLB)
to market and distribute MUSE.
This news release contains forward-looking statements about the
potential commercialization of products in treating female sexual
dysfunction and reflects management's current beliefs. However, as
with any pharmaceutical under development, there are significant risks
in development, regulatory approval and commercialization of new
products. There are no guarantees that any product will receive
regulatory approval for any indication. Further, even if the Company
were to receive regulatory approval for a product, there could be no
assurance that such a product would prove to be commercially
successful. Please see the Company's filings with the Securities and
Exchange Commission including, without limitation, the Company's Form
10-K and Forms 10-Q, which identify these and other risks and
uncertainties that may cause actual results or events to differ
materially from those described in this news release.
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CONTACT: VIVUS, Inc.
Richard Walliser
650/934-5200
ir@vivus.com
www.vivus.com
or
The Investor Relations Group (Media Contact)
Lisa Lindberg (theproteam@aol.com)
212/825-3210
or
Lippert/Heilshorn & Associates, Inc. (Investor Contacts)
Bruce Voss (bvoss@lhai.com)
Jody Cain (jcain@lhai.com)
310/691-7100 |
