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A Better NSAID: Pozen / AstraZeneca
Dec.
Dec.
3,
3,
2008-
2008-
POZEN
POZEN
Announces
Announces
Positive
Positive
Top
Top
Line
Line
Results
Results
for
for
Its
Its
PN
PN
400
400
Phase
Phase
3
3
Trials
Trials
POZEN
POZEN
Inc.
Inc.
(NASDAQ:
(NASDAQ:
POZN),
POZN),
today
today
announced
announced
positive
positive
Phase
Phase
3
3
trial
trial
results
results
for
for
its
its
PN
PN
400
400
product
product
candidate
candidate
(enteric
(enteric
coated
coated
naproxen
naproxen
500
500
mg
mg
and
and
immediate
immediate
release
release
esomeprazole
esomeprazole
20
20
mg)
mg)
conducted
conducted
by
by
POZEN
POZEN
under
under
an
an
agreed
agreed
Special
Special
Protocol
Protocol
Assessment
Assessment
with
with
the
the
FDA.
FDA.
Both
Both
the
the
PN
PN
400-301/302
400-301/302
studies
studies
achieved
achieved
the
the
primary
primary
endpoints.
endpoints.
Subjects
Subjects
taking
taking
PN
PN
400
400
experienced
experienced
statistically
statistically
significantly
significantly
fewer
fewer
endoscopically
endoscopically
confirmed
confirmed
gastric
gastric
ulcers
ulcers
on
on
PN
PN
400
400
compared
compared
to
to
subjects
subjects
receiving
receiving
enteric
enteric
coated
coated
naproxen
naproxen
during
during
the
the
six-month
six-month
period.
period.
In
In
each
each
of
of
the
the
trials,
trials,
approximately
approximately
400
400
subjects
subjects
received
received
either
either
PN
PN
400
400
or
or
enteric
enteric
coated
coated
naproxen
naproxen
500
500 • 505(b)(2)
mg,
mg,
twice
twice
daily,
daily, Phase
over
over
a
a 3
six-month
six-month trial results
treatment
treatment for
period.
period. PN
Subjects
Subjects 400 product
underwent
underwent
upper
upper
endoscopies
endoscopies
at candidate at
baseline
baseline
and
and (enteric at
at
one,
one,
three,
three, coated and
and
six
six
months naproxen months
with
with
the
the 500 primary
primary mg endpoint
endpoint and as
as
the
the
cumulative
cumulative
incidence
incidence
of
of
gastric
gastric
ulcers.
ulcers.
The
The
FDA
FDA
has
has
recently
recently
informed
informed
POZEN
POZEN
that
that
the
the
appropriateness
appropriateness immediate
of
of
this
this
endpoint
endpoint release
is
is
the
the
subject
subject esomeprazole,
of
of
an
an
internal
internal
review
review Nexium,
and
and
an
an
FDA
FDA 20 mg
internal
internal to
meeting
meeting
is
is
planned
planned
in
in
Q1 provide Q1
2009
2009
to
to
discuss gastroprotection) discuss
this
this
matter.
matter. … statistically significantly
POZEN
POZEN
and
and
AstraZeneca
AstraZeneca
entered
entered
into
into
a
a
co-development
co-development
agreement
agreement
for
for
PN
PN
400
400
in
in
August
August
2006.
2006.
PN
PN
400
400
is
is
an
an 400
investigational
investigational compared
product
product to
under
under subjects
clinical
clinical
development
development receiving
in
in enteric
patients
patients
who
who coated
require
require
chronic
chronic
non-steroidal
non-steroidal
anti-inflammation naproxen anti-inflammation during drug
drug
(NSAID)
(NSAID) the six-month treatment
treatment
for
for period. arthritis
arthritis
pain,
pain,
such
such
as
as
osteoarthritis
osteoarthritis
and
and
who
who
are
are
at
at
risk
risk
for
for
developing
developing
NSAID-associated
NSAID-associated
gastric
gastric
ulcers.
ulcers.
The
The
NDA
NDA
submission
submission
is
is
planned
planned
for
for
mid-2009.
mid-2009.
27
fewer endoscopically confirmed gastric ulcers on PN
• An estimated 25-30% of NSAID prescriptions are
accompanied by a gastroprotective agent.
• 60M people take NSIADs in the US, with serious GI
events in 1-2%.
© Defined Health, 2009
Pain Insight Briefing