The
Company
is also working with various pharmaceutical companies to explore
the incorporation of NexACT into
their existing drugs as a means of
developing new patient-friendly transdermal products and extending
patent
lifespans and brand equity.1 (baseline of 22.com.
Such examples are impotence, decreased
testosterone, prostate difficulties, penis size issues and other various sexual performance conditions
and causes.
testicles dysfunctions
Gittelman's four presentations are titled:
-- Synergistic effect of meatal application
of dyclonine/alprostadil
cream for the treatment of Early Ejaculation ("EE") in a double-blind
and
crossover study
-- The use of the female sexual function index to assess the efficacies
of an alprostadil cream in a placebo-controlled, double-blind study in
patients with female
sexual arousal disorder
-- A placebo-controlled, double-blind study of the efficacy and safety
of
an alprostadil topical cream in patients with female sexual arousal
disorder
-- Effects of an alprostadil cream on sexual arousal response in
premenopausal women with female
sexual arousal disorder
Copies of the abstracts are available through NexMed. VIVUS currently
markets
MUSE(R) (alprostadil) suppository in the U.premature transmitted
4%, respectively, of patients during in-clinic
dosing, MUSE titration
should be carried out under medical supervision.erectile decreased
PRESS RELEASE NexMed Presents
New Data at ESSM Including Data on Early Ejaculation Product
Gittelman's presentations will include
data on NM100061,
NexMed's proprietary early ejaculation ("EE") treatment under development. "The
approximate four-fold improvement in the
ability to have natural erections without the use of erectogenic
aids in the
MUSE group is clinically significant in this group of subjects.
About MUSE
MUSE (alprostadil) is a medicated pellet that is placed in the urinary
opening using a disposable
plastic applicator. is a pioneer in the research and development of proprietary
products to restore
sexual function for women and men.untreated penis
SAN ANTONIO, VIVUS, Inc.
A total of 91 preoperatively
sexually active patients who developed ED due
to a bilateral nerve-sparing RP were enrolled in the
study. MUSE should not be used by men who have sickle cell anemia or
trait, leukemia or tumor of
the bone marrow, allergy to alprostadil (the
active ingredient in MUSE), or abnormal penile anatomy
.
Certain statements in this press release are forward-looking within the
meaning of the
Private Securities Litigation Reform Act of 1995.healthlink varicoceles
Positive Clinical Data Demonstrates Early MUSE
(R) Therapy Following Radical Prostatectomy Enhances Penile Recovery and Improves Penile Function
Erectile function was assessed before and at six months after surgery in
both groups using
the Sexual Health Inventory for Men (SHIM), a patient
questionnaire that determines the degree of
erectile dysfunction in which
higher scores indicate better function.0) for the control group (p<0
. It has not been approved
by the FDA for the recovery of normal erectile function following radical
prostatectomy. MUSE does not protect against sexually transmitted diseases.testosterone genital
NexMed, Inc. As
with any pharmaceutical under
development, there are significant risks in the development, regulatory
approval and commercialization of new products.ejaculation andropause
Unlike Johnson and Johnson's Dapoxetine, an oral
treatment under development, NM100061 is applied locally.D. The six-month SHIM scores for the
MUSE
-treated group was 18.S.ejaculation prostate
(Nasdaq: VVUS)
today announced the presentation of results from a study to
evaluate the
effects of the early use of MUSE(R) (alprostadil) urethral suppository on
erectile
dysfunction (ED) subsequent to a bilateral nerve-sparing radical
prostatectomy (RP) in men with prostate
cancer. The study also showed
that 74% of patients who completed six months of MUSE treatment were
able to
resume sexual activity. Research from the 2002 National
Hospital Discharge Survey found
that 195,000 prostatectomy procedures were
performed in 2002 as a means of treating prostate cancer
. These
statements may be identified by the use of forward-looking words such as
"anticipate,
" "believe," "forecast," "estimated" and "intend," among others.premature manorexia
Marc Gittelman, MD, FACS, Director of
the Miami
Center for Sexual Health and a NexMed consultant, will make four
presentations at the
8th Annual Meeting of the European Society for Sexual
Medicine ("ESSM"), which takes place December
4-7, 2005 in Copenhagen,
Denmark. at the Annual Meeting of the American Urological
Association
in San Antonio, Texas. Fifty-six patients
were treated with MUSE, three times per week for six months
.
In contrast, only 11% of subjects in the observational control group were able
to achieve erections
sufficient for intercourse without treatment six months
after surgery. For men, VIVUS is developing
avanafil for erectile
dysfunction, which is currently in a Phase 2 program. For more information
on clinical trials and products, please visit the Company's web site at
http://www.decreased flowchart
Dr. Rupesh
Raina, M. MUSE should not be
used in men for whom sexual activity is inadvisable due to cardiac fitness
. Side effects can include penile pain. Phase
2 development for Testosterone MDTS(R) for the treatment
of hypoactive sexual
desire disorder has been completed. The MDTS system is a patented
new-generation
, transdermal drug delivery technology that delivers drugs
through the skin. VIVUS does not undertake
an obligation to
update or revise any forward-looking statement.genital testicles
Dr. is an emerging drug developer
that is leveraging its
proprietary drug technology to develop a significant pipeline of innovative
pharmaceutical products to address significant unmet medical needs. During post-marketing
surveillance
syncope occurring within one hour of administration has been
reported.overweight wellman
EE, commonly known as premature
ejaculation, is the most prevalent male
sexual dysfunction, affecting as many as one-third of men
worldwide at some
time in their lives. Treatment was
initiated approximately three weeks after
surgery with 125 mcg of MUSE; after
6 weeks, the dose of MUSE was either increased to 250 mcg or
was maintained at
125 mcg for an additional 4 months. VIVUS' current product
pipeline includes
four investigational products in late stage clinical
development.
transmitted epididymitis
NexMed, Inc. Because
of
the potential for symptomatic hypotension and syncope, which occurred in 3%
and 0.
ejaculation varicoceles
Both
groups had similar baseline
levels of erectile function before surgery. As erectile
dysfunction
associated with a radical prostatectomy can persist for 12 to
24 months, any treatment that would
reduce this time would be of significant
benefit to the patient."
A total of 18 men in the
MUSE group discontinued treatment prior to the
end of the study, nine for insufficient erections
, five for reduced sexual
interest and four for local pain/burning. For women, VIVUS has initiated
its Phase 3 programs with
ALISTA(TM) (topical alprostadil) for female sexual arousal disorder, and
Evamist(TM) (estradiol MDTS) for the alleviation of menopausal symptoms.prevalent healthlink
The remaining 35 patients
received no
treatment and comprised the control group. Sexual dysfunction
is a frequent consequence
of this type of surgery, most likely due to damage
to local nerves and blood vessels. There are
a number of factors that
could cause actual events to differ materially from those indicated by such
forward-looking statements.testicles prostate
net. and internationally through
distributors for the treatment of
erectile dysfunction.atrophy flowchart
These results were presented
by Dr. For
complete efficacy and safety information
, please see the full prescribing
information available at http://www.erectile prostate
05).wellman testicles
2) compared to the score
of
12. Patients should be cautioned to avoid activities such as driving or
hazardous tasks, where
injury could result if hypotension or syncope were to
occur after MUSE administration.vivus.prevalent testicles
About NexMed, Inc.
According to the American Cancer Society, more than 230,000 men were
diagnosed
with prostate cancer in 2004. 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.gynecomastia testes
Thirty-eight patients in the MUSE-treated group continued
treatment for
the duration of the study, and of these, 39% were able to achieve natural
erections
sufficient for intercourse without the use of erectogenic agents. MUSE was approved by the FDA in
1997
for the treatment of erectile dysfunction (ED).
MUSE should not be used for intercourse with a pregnant
woman without a
condom. Investors should read the
risk factors set forth in VIVUS' Form 10-K
for the year ended December 31,
2004 and periodic reports filed with the Securities and Exchange
Commission., +1-650-934-5240.atrophy flowchart
The study was conducted at the Cleveland
Clinic in Cleveland, Ohio
.prostate penis
A single surgeon
performed the radical prostatectomy for all study patients.
"Results from
this study suggest that early treatment with MUSE after a
radical prostatectomy may improve penile
function recovery," commented Dr.
Raina, lead author of the study.muserx.
About VIVUS
VIVUS, Inc.Conditions and diseases prevalent to men are many and often go untreated.
testicles transmitted
(NASDAQ:
NEXM), a developer
of innovative treatments based on the NexACT drug delivery technology,
today
announced that Dr.9 (baseline of 21.
These forward-looking statements are based on VIVUS' current
expectations and
actual results could differ materially.
CONTACT: Christina Weisgerber
of VIVUS, Inc.transmitted prevalent
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