The result -- the
development
of patented Zestra(TM) Feminine Arousal Fluid -- the only topical
product clinically proven to increase
female sexual sensation, arousal and
pleasure in most women.
yoi stimulants
A positive trend was observed in all
treatment groups from week four compared with baseline. In the most effective
treatment group
, the number of satisfactory sexual events more than doubled at
week 16 compared with baseline. MDTS
features a small, discrete, hand-held applicator that
delivers a pre-set dose of a proprietary formulation
of testosterone to the
skin where it is released into the blood stream on a sustained basis over
24
hours.Zestra(TM) - First Clinically Proven Arousal Solution for Women Addresses Decreased Sexual
Sensation
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"This is also the
first at-home clinical trial to validate the ability of the MDTS
technology to
effectively deliver an adequate amount of testosterone to improve sexual
response
.
CONTACT:
VIVUS Inc. New Study Reveals More Than 48% of Women Suffer From Decreased
Sexual
Sensation
CHARLESTON, S.2156
eross@kupperparker.satisfied aphrodisiacs
The most common side effect was a mild increase in hair growth,
resulting
in only two patients withdrawing from the study, both in the highest
dose group.
Christina
Weisgerber
+1-650-934-5240
C., A new study published in the
American Journal
of Obstetrics + Gynecology (ACOG, Vol. Citations include:
-- Obstetrical and Gynecological
Survey published a Continuing Medical
Education (CME) Review Article that acknowledges the
benefits of
Zestra(TM) for both arousal and orgasmic difficulties.
(5) Jean L.erections sativa
is a
pioneer in the research and development of proprietary
products to restore sexual function for men
and women. However, several well-designed, well-controlled clinical studies
conducted by sexual medicine
researchers have shown that increasing blood flow
to the female genital tissues does not necessarily
provide an increase in
female sexual sensation, arousal or pleasure. Pauls, MD, Steven D.keltech stimulant
05) increase
in the
number of satisfactory sexual events at week 16 for the second highest dose of
testosterone
MDTS compared to placebo.
Certain statements in this press release are forward-looking within
the
meaning of the Private Securities Litigation Reform Act of 1995.
However, they overlooked
the complex "pleasure pathways" crucial for women to
experience sexual sensation, arousal and pleasure
. "Oral prescription erectile dysfunction drugs work
by increasing blood flow via the nitric oxide
pathway, which facilitates
engorgement of male erectile tissue. 2003; 63(14): 1445-1457.
satisfied aphrodisiac
For more
information
on clinical trials and products, please visit the Company's web site at
http://www
. Investors should read the risk
factors set forth in VIVUS' Form 10-K for the year ended December
31, 2003 and
periodic reports filed with the Securities and Exchange Commission. Drugs.stimulants phyto
Testosterone MDTS(R)
Testosterone (Metered Dose Transdermal Spray) is a patented new-generation
transdermal spray. The MDTS spray is fast drying, non-irritating and invisible after
application
. VIVUS does not undertake an obligation to
update or revise any forward-looking statement." This
finding is a landmark
development in female sexual function research and provides the underlying
reason why major drug companies have been unsuccessful in developing an
effective prescription
drug treatment for FSD.
Topical Solution Specifically Designed To Increase Female Sensation
and
Pleasure
In 1996, pharmaceutical researcher Martin Crosby recognized that the
primary
research direction of major drug companies exploring potential
treatments for FSD were focused on
increasing genital blood flow in women. The study, designed and conducted by independent
sexual medicine
experts, found that "Zestra improved level of desire,
satisfaction with level of sexual arousal,
genital sensation, sexual pleasure,
ability to have orgasms and enhancement of sexual experiences
in normal and
FSAD women." No other topical product for women is proven in a published
clinical
study to provide these benefits." Zestra(TM) was part of several presentations
about female sexual
problems and menopause made by doctors at the conference. Zestra(TM) will also be
available in CVS
pharmacies by mid-June and is expected to be available at
other major pharmacy chain stores by mid
-summer 2005. MS
Motivator. When It Comes to Botanical
Prosexual Preparations,
Clinicians and Consumers Beware! Women's
Health Care.erections arousal
For men, VIVUS is developing avanafil
for erectile
dysfunction, which is currently in a Phase 2 program. There are a number of factors
that
could cause actual events to differ materially from those indicated by such
forward-looking
statements.
"Since the introduction of Viagra(R) in 1998, there has been an industry
scramble
by drug companies to develop what is often referred to as 'Viagra for
Women,'" continues Crosby.
(2) Rachel N.detoxification pheromones
Phase 2 Study Shows Number of Satisfactory Sexual Events more than Doubled
MOUNTAIN VIEW, Calif.
These forward-looking statements are based on VIVUS' current expectations
and
actual results could differ materially.
Zestra(TM) is currently available at Walgreens
pharmacies nationwide and
Duane Reade drugstores throughout New York City. Karram, MD. 2005; 60
(3): 202-205. 2004 Fall; 15.virilplant arousal
com.(1)
Recently, several leading medical journals have cited the
benefits of
Zestra(TM) for women suffering from sexual difficulties.
(1) Ferguson
D, Steidle C, Singh G, et al. Clinical Proceedings. Fourcroy.
Media Contact: Emily
Ross
314.impotency erections
The study was conducted at 6 sites across Australia by Acrux Limited
(ASX: ACR), under an Investigational New Drug (IND) Application on file with
the United States
Food and Drug Administration (FDA).(2)
-- The May 2005 edition of Clinical Proceedings, a publication
by the
Association of Reproductive Healthcare Professionals (ARHP), cited
Zestra
(TM) an option for women with sexual arousal difficulties.(3)
-- "Rediscovering Intimacy" published
in the Multiple Sclerosis
Association of America's publication Motivator. QualiLife Pharmaceuticals
believes this "design and
develop" strategy increases the chances of successfully developing effective
and widely embraced consumer products.keltech hormonal
"
"Testosterone MDTS is an important component of our
entire development
pipeline, which includes ALISTA(TM) for the treatment of Female Sexual Arousal
Disorder and Evamist(TM) for the treatment of menopausal symptoms, both
currently in Phase 3 development
," commented Leland Wilson, President and CEO
for VIVUS. VIVUS currently markets
MUSE(R) (alprostadil
) suppository in the U.S. These factors include, but are not limited to,
substantial competition;
uncertainties of patent protection and litigation;
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. There are no guarantees that
future clinical studies discussed in this press
release will be successful or
that any product will receive regulatory approval for any indication
or prove
to be commercially successful. 192, No.
Only Clinically Proven, Medically Published
Topical Product Available
In 2003, the Journal of Sex + Marital Therapy published the results
of
Zestra's(TM) clinical trial.S. The natural botanical ingredients
in Zestra are not found in
any other women's sexual product and no other
product is proven to be more effective for increasing
female sexual sensation,
arousal, pleasure and satisfaction. Kleeman, MD, and Mickey M.vuka aphrodisiacs
acrux. For
women, VIVUS has initiated its Phase 3 programs with
ALISTA(TM) for female sexual arousal disorder
, and Evamist(TM) for the
alleviation of menopausal symptoms. The objective of
the CME Review
Article titled "Female Sexual Dysfunction: Principles
of Therapy" is to provide the most
current clinical information
available to Obstetricians, Gynecologists and Family Practice
physicians on the topic of female sexual dysfunction and the principles
of diagnosis
and therapy.zestraforwomen. Since 1996,
the privately-held Company has leveraged its expertise in
pharmacology,
pharmaceutical technology and women's sexual health to "design and develop"
selected
plant-derived principles as patented consumer products with
significant commercial potential.yohimbin libido
Acrux
has completed sixteen human clinical trials
with six different drugs using its proprietary drug delivery
technology,
comprising ACROSS(R) penetration enhancers, Metered Dose Transdermal System
(MDTS
(R)) applicators for transdermal administration, and Patchless Patch(R)
delivery method.
About VIVUS
VIVUS Inc. Crosby founded QualiLife
Pharmaceuticals and began work on a non
-prescription, all-natural solution for
women suffering from many widespread sexual problems.(4)
-- "Female Sexual Dysfunction. For years, many researchers thought that
the same robust benefits
could be achieved in women by increasing genital
blood flow.com .
* Viagra(R) is a registered
trademark of Pfizer Inc.erections ascend
About Acrux
Acrux Limited's group of companies is engaged
in the development and
commercialization of a range of patented, patient-preferred healthcare
products
for global markets. For more
information please visit the Company's web site at http://www. Potential
Therapy for Pharmacotherapy"
published in Drugs.(6)
"Zestra(TM) was embraced
by physicians and nurse practitioners attending
the American College of Obstetricians and Gynecologists
Conference (ACOG), in
San Francisco May 7-11, 2005," said pharmacist Martin Crosby, QualiLife
Pharmaceuticals
' Chief Scientific Officer and inventor of Zestra(TM). Randomized, placebo controlled,
double
blind, crossover design pilot trial of the efficacy and safety
of Zestra for women in women
with and without female sexual arousal
disorder.
(4) Sabitha Pillai-Friedman, PhD
, LSW, Part III: Regaining Intimacy.com
stimulant detoxification
(Nasdaq: VVUS) today announced that clinical data
from a Phase 2 study showed
treatment with the Company's Testosterone MDTS(R), an investigational
transdermal testosterone spray, significantly increased the number of
satisfactory sexual events
in premenopausal women with Hypoactive Sexual
Desire Disorder (HSDD).au. 5, May 2005)
by researchers
at Yale School of Medicine and the Albert Einstein College of
Medicine reports, "female sexual dysfunction
(FSD) affects 48. Patent
6,737,084)
Zestra(TM) is a blend of pure botanical oils and other
natural ingredients
scientifically formulated to heighten sexual sensation, arousal and pleasure
for 30 to 45 minutes when topically applied. is a science-driven company focused on
developing
clinically proven consumer products for Women's Health. The Company applies its integrated
scientific
platform with natural products to specific target areas where it
has substantial expertise.phyto aphrodisiacs
Acrux
's portfolio includes treatments of hormonal
deficiencies, pain, central nervous system disorders
and urinary incontinence,
as well as a contraceptive. Acrux has also
licensed its technology for
commercial development to Eli Lilly for veterinary
healthcare products, and to Connetics Australia
, a subsidiary of the US
Company Connetics, for anti-psoriatics and local anesthetics. VIVUS' current
product
pipeline includes four investigational products in late stage clinical
development.
Clinical Proceedings is part of the Nurture Your Nature initiative, a
joint program
of ARHP and the National Women's Health Resource Center
to raise awareness about sexuality
as a natural and valued aspect of
American women's lives, with a focus on menopausal women
.
Female Sexual Dysfunction: Principles of Diagnosis and Therapy.hormonal avena
The 28-week, double
-blind, randomized, placebo controlled, dose-ranging
study consisted of 261 premenopausal women with
low serum testosterone and low
libido that caused distress. Patients were randomized to receive a
once daily
administration of Testosterone MDTS or placebo spray to the abdomen over a
16-week
treatment period. The primary endpoint of the study was the number of
satisfactory sexual events
reported by women over a 4-week period at week 16. More
information is available at http://www.
About QualiLife Pharmaceuticals, Inc.
(3) Women's Sexual Health in Midlife and Beyond
.ascend avena
"This is the first double-blind, placebo controlled study conducted under
an IND Application
evaluating the safety and efficacy of transdermal
testosterone in premenopausal women with low testosterone
," said Peter Tam,
Senior Vice President of Product and Corporate Development. These
statements
may be identified by the use of forward-looking words such as
"anticipate," "believe," "forecast
," "estimated" and "intend," among others.. Potential for
Pharmacotherapy.290.hormonal keltech
, VIVUS Inc
. The incidence of skin irritation was very low and reported as
mild.
"Earlier studies have
demonstrated the efficacy of transdermal
testosterone delivery for the treatment of naturally and
surgically menopausal
women.2 percent of
women and that these women had decreased sensation in
the clitoris, which
increased the risk of sexual dysfunction.
Ingredients: PA-Free Borage
Seed Oil, Evening Primrose Oil, Angelica
Extract, Coleus Extract, Vitamin C, Vitamin E and natural
fragrances.
(6) Susan Kellogg-Spadt, MSN, CRNP, PhD.carbonated libido
Clinical Trial Demonstrates Improved Sexual
Desire in Women with Low Libido After Treatment with VIVUS' Testosterone Spray
No serious adverse
events resulting in
discontinuation of the study occurred in any subject receiving testosterone
MDTS
. Acrux has licensed USA rights to its two lead
products, Estradiol MDTS(R) and Testosterone MDTS
(R), to VIVUS and AUS/NZ
distribution rights for Testosterone MDTS(R) to CSL Limited. Testosterone
MDTS(R) for the treatment of
HSDD has completed Phase 2 development. The MDTS system is a patented
new-generation, transdermal drug delivery technology that delivers drugs
through the skin. and
internationally through
distributors for the treatment of erectile dysfunction.vivus."
About Non-Prescription Zestra(TM) Feminine Arousal Fluid (U.
Obstetrical and Gynecological
Survey. Female Sexual Dysfunction.avena vuka
Study results showed a statistically significant (p<0.(5)
-- When It Comes to Botanical Prosexual Preparations, Clinicians and
Consumers Beware
!" published in Women's Health Care. Crosby
added, "Those already familiar with Zestra(TM) said their
patients were raving
about it and those who first learned of Zestra(TM) at the conference were
delighted
to have a proven product with published clinical study results to
recommend to their patients. These
target areas primarily involve
female sexual health, and other late-stage pipeline products that
deliver
substantial quality of life enhancements in women's health.
2005 May: 26-27. 2003
Nov; 2 (11).virilplant arousal
This new study supports the findings of our earlier study that
premenopausal women with
low libido can also enjoy an increase in satisfactory
sexual events following treatment with transdermal
testosterone," said Susan
Davis Professor of Women's Health at Monash University and Principal
Investigator
.com. As with any pharmaceutical under
development, there are significant risks in the development
, regulatory
approval and commercialization of new products. J Sex Marital Ther 2003; 29:33-44.aphrodisiac detoxification
QualiLife Pharmaceuticals, Inc.Aphrodisiacs are products which are claimed to enhance or increase
sexual performance.
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