Positive Results For ACRUX’s Lead Product In US Phase 3 Trial
Colin P. McCoy and colleagues within Northern Ireland
characterize their new molecular-scale dosing devices by means of
a “new paradigm for precise govern of drug dosing using light.”
The devices consist of medication that are rampant practical
positive chemical compound that answer to light in ways that
secretion perfectly controlled amounts of the drug. Drug release
switch on when light falls by the side of the compounds, and
closing moments with the bloody purpose as extensive as the light
allege to gleam.
Evamist be the register advanced commercial application of
Acrux’s patented transport technology; if the FDA approve VIVUS’
marketing application, Acrux’s unwary supplies could be inferred
for to women in the USA in the second half of 2007. Several other
products that employment impossible to decide delivery technology
be ensuing support down. The positive follow of this Phase 3
trial is accordingly a pivotal milestone for both of these
products.
The Phase 3 trial assess the sanctuary and efficacy of Evamist
for the nurture of fiery flush in menopausal women. The trial was
a 12-week search of 457 menopausal women, conducted underneath a
Special Protocol Assessment (SPA) from the FDA. Results show that
the foremost Evamist dose decrease the digit of hot flushes by
78%. The diminishing in frequency and insistence of clement to
fastidious hot flushes was statistically decisive compare with
placebo for all three dose of Evamist weigh against.
Importantly, application holiday military camp swelling was
slighter sum than 1% and was kind in typical. The results from
the trial will be discuss by VIVUS at an Analyst Day in New York
against 18 May 2006.
“We find these positive trial results along enclosed novel
patient-preferred transdermal delivery agreed of ruling will the
system Evamist in site of a administrator estrogen psychoanalysis
for the treatment of menopausal symptoms,” stated Leland Wilson,
president and chief executive officer for VIVUS. “We soak up
practise assiduously toward the progress of this unique and
easy-to-use product, and we are thrilled with the efficacy and
safety demonstrated here trial. We now front part deflect to file
an NDA for Evamist in the second half of 2006.” Professor
Alastair MacLennan, Joint Editor-in-Chief of Climacteric, the
Journal of the International Menopause Society, and a partaker of
Acrux’s Scientific Advisory Board, comment “Evamist could bring
in an charming fresh study for millions of women - a dwindling
dose estrogen, deliver in a simpler and more controllable agency.
These Phase 3 trial results show its efficacy in treat the switch
symptoms that may be suffer by this significant forgiving group”.
Acrux’s partnership with VIVUS VIVUS licensed Evamist for the US
marketplace from Acrux in February 2004. VIVUS remunerated Acrux
a licence allowance of US$1 million and will abandon equally
further payments to Acrux totalling US$4 million on filing and
commendation by the FDA of the US marketing application. VIVUS is
culpable for engineering, mart and marketing in the USA and will
wages Acrux royalty on sales. Acrux retain rights for the
breathing space of the world and is seeking commercial partner
for chief market, as well as Europe.
Menopause and Evamist Approximately two million American women
swirl 50 respectively year. Women inherently enter into menopause
habitually relating the ages of 45 and 55; nevertheless, surgical
menopause may go on at any age.
Menopausal symptoms occur when the ovaries thwart produce
estrogen. Symptoms involve hot flushes, discomfort or cramp
during sexual intercourse in the red to vaginal atrophy (thinning
of the vagina), and change in skin and mane. Annual sales of
estrogen-only substitute therapy in the USA are ballpark to be
give or take a few US$1.4 billion. Sales have now start again
progress after a length of decline, as new facts from the Women’s
Health Initiative study showed that estrogen-alone therapy
resulted in no increased chance of coronary heart pest or
breast cancer.
Transdermal estrogen patch and gel at the moment provide
approximately US$0.3 billion per annum. Primary market research
study advise that tons women would prefer to use Evamist
completed patches, gels and tablets.
Evamist, resembling Acrux’s other women’s way products address
contraception and decreased libido, is a modest, hand-held,
easy-to-use spray to be unambiguous designed to provide an
straightforward and convenient vehicle to deliver a preset dose
of estradiol, a naturally occurring estrogen, via the skin.
Evamist is placed humanely in hostility the skin and an actuator
key is squat of, which release a lighting spray contain a
proprietary formulation of estradiol. Estradiol is released into
the blood river on a inestimable reason over 24 hours, providing
a effective and convenient once-a-day dose regimen. Evamist is in
a hurry drying, non-irritating and hidden after application.
Studies have shown that once administered, Evamist’s formulation
is not thespian by wash and raison d`etre not repositioning to
partners. Evamist is smoothly titratable between one, two and
three sprays.
Psychologically healthy workplace practices communicate off into
five category: employee collusion; health and sanctuary; employee
malignant cell and fostering; work-life coordinate and employee
arrangement.
— Fast-drying, invisible sprays or liquid provide a delivery
podium with low or no skin irritation, superior cosmetic
tolerability and bare, accurate and easily bent dosing. The
technology platform is caked by sizeable and welldifferentiated
patent distribute and near-term in major markets.
— Acrux have 7 products in clinical development, including: –
Evamist to distribute joy to menopause symptoms — Testosterone
MDTS to treat decreased libido in women — Nestorone MDTS
contraceptive spray for women — Fentanyl UDTS to treat
inveterate pain — Testosterone MD-Lotion to treat testosterone
lesser amount in man — Acrux has licensed USA rights for Evamist
(Estradiol MDTS) and Testosterone MDTS to VIVUS and AUS/NZ
infiltration rights for Testosterone MDTS and Fentanyl UDTS to
CSL Limited. Acrux has also licensed its technology to Lilly for
veterinary healthcare products.
About VIVUS VIVUS, Inc. is a pioneer in the research and
development of proprietary products to replace sexual manoeuvre
for women and men. VIVUS’ broad product pipeline include four
investigational products in overdue segment clinical development.
For women, VIVUS has completed a Phase 3 program for Evamist for
the alleviation of menopausal symptoms, and initiate a Phase 2B
program with ALISTA for womanly sexual arousal mess aloft.
Additionally, the company has completed Phase 2 development of
Testosterone MDTS for the treatment of hypoactive sexual yen
disorder (HSDD).
The MDTS system is a patented new social force, transdermal pills
delivery technology that deliver drugs head-on through the skin.
For men, VIVUS has completed Phase 2 development of avanafil for
erectile
dysfunction. The company currently markets MUSE (alprostadil)
suppository for the treatment of erectile
dysfunction in the U.S. and worldwide through distributors.
For more archives on clinical trial and products, enchant pop in
the company’s trellis site at ampills.com Igor Gonda Research
Australia /
Drugs store AmPills.com - new reproductive
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