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 etude sur l' " aspromeprazole" de pozen

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AuteurMessage
laurent



Nombre de messages : 339
Age : 49
Localisation : PARIS
Date d'inscription : 16/09/2007

MessageSujet: etude sur l' " aspromeprazole" de pozen   Jeu 6 Mai - 16:49

POZEN Reports PA65020 Significantly Reduces the
Incidence of Upper GI Damage in Healthy Adults




Press Release
Source: POZEN Inc.

On Thursday May 6, 2010, 8:35 am EDT


CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN
Inc. (NASDAQ:
POZN - News) today announced
that results of a Phase 1
Trial of PA65020, a combination of enteric-coated aspirin (EC-ASA)
and
immediate-release (IR) omeprazole, show PA65020 significantly
reduces
the incidence of gastrointestinal (GI) mucosal damage compared to
EC-ASA
(650 mg twice daily) in healthy adults treated for one month.
Patients
receiving analgesic doses of EC-ASA were five times more likely to

experience significant GI mucosal damage than patients receiving
PA65020. The study concluded that PA65020 may provide an important

therapeutic option for at-risk patients who require analgesic
doses of
aspirin. Data will be presented on May 7th at the 29th

Annual Scientific Meeting of the American Pain Society (APS) in
Baltimore, MD, being held May 6-8. Data will also be included in a

supplemental issue of the Journal of Pain.The
benefits of aspirin are well-documented and more than five billion
units of aspirin in all of its forms are sold in the U.S. each
year. But
because aspirin is linked with significant GI damage, it may be
underutilized for both secondary prevention of cardiovascular
disease as
well as pain. “We are pleased to report that PA65020 reduces the
incidence of upper GI damage compared to aspirin therapy,” said Dr. John
Fort, Chief Medical Officer, POZEN. “These results are promising
for the
millions of people who could benefit from analgesic doses of
aspirin
therapy, but are at risk for upper GI damage from this treatment.”About
the Study
The study examined 40 healthy adults with normal
gastroduodenal
endoscopy, defined as a Grade 0 Lanza score, at baseline. Dosing
schedules were as follows: PA65020 (fixed dose combination of
EC-ASA 325
mg and IR omeprazole 20 mg, and EC-ASA 325 mg) was administered as
two
tablets twice daily; EC-ASA 650 mg was administered as two 325 mg
tablets twice daily. On day 28 of therapy, 15% of the PA65020
treatment
group versus 85% of the EC-ASA treatment group had Grade 3 or 4
Lanza
scores (P<0.001), the study’s primary endpoint. In addition,
65% of
subjects in the PA65020 group had Grade 0 Lanza scores, meaning no

visible gastroduodenal lesions, versus 0% of subjects in the
EC-ASA
group. In addition, no patients in the PA65020 treatment group
developed
a gastric/duodenal ulcer versus 8 patients (40%) of those in the
EC-ASA
treatment group (P=0.003) at day 28. No serious adverse events
were
reported and there were no withdrawals due to adverse events in
either
treatment arm.About PA65020PA65020 is part of
the PA franchise under development by POZEN. The PA
products utilize a patented technology, developed by POZEN, which
allows
for sequential release of the active components and protects the
stomach
in advance of the release of the gastric offending agent. This
same
proven technology is the basis for VIMOVO™, (naproxen and
esomeprazole
magnesium) delayed-release tablets, approved by the Food and Drug
Administration (FDA) on April 30, 2010 for the relief of the signs
and
symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and
ankylosing spondylitis (AS) and to decrease the risk of gastric
ulcers
in patients at risk of developing non-steroidal anti-inflammatory
drug
(NSAID) associated ulcers. VIMOVO is co-developed by POZEN and
AstraZeneca. POZEN’s safer form of aspirin, the PA franchise, has
the
potential to expand the use of aspirin by significantly improving
the
tolerability and reducing the risk of GI toxicity issues
associated with
aspirin therapy.
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