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New Long-Term Safety and Quality of Life Data Reported for

ZORVOLEX in Osteoarthritis Patients

SoluMatrix Fine Particle Technology(TM) is a trademark of iCeutica Inc.,


and the technologies can be certified for you to Iroko for exclusive use within NSAIDs.
PHILADELPHIA--(BUSINESS WIRE)--Iroko Pharmaceuticals, LLC, the global specialty
pharmaceutical organization
devoted for you to advancing the particular science of analgesia, these days announced in which
ZORVOLEX (diclofenac) capsules has been usually well tolerated and also
improved the health-related standard regarding living (HRQOL) in patients together with
osteoarthritis pain, depending on a 12-month, open-label Stage 3 study1,2.
These kind of information are being introduced in the American University regarding Rheumatology
2014 Annual Meeting, November 14 -19 inside Boston. ZORVOLEX, any nonsteroidal
anti-inflammatory drug (NSAID), ended up being approved from the united States Meals
as well as Drug Administration (FDA) in August 2014 for the management involving
osteoarthritis pain plus October 2013 for that remedy involving mild to
reasonable acute pain within adults.
"It is essential for almost all associated with us to assess the safety of new medicines utilized in
patients using osteoarthritis regarding extended periods, because they usually need
long-term management," said Dr. Roy Altman, Professor associated with Medicine throughout
Rheumatology with UCLA and also lead research author.
Long-term administration involving NSAIDs can lead to renal papillary
necrosis as well obat untuk nyeri sendi as other renal injury. ZORVOLEX needs to be employed
together with caution in
patients from greatest risk of this reaction, including your elderly, those
using impaired renal function, coronary heart failure, liver dysfunction, along with

those using diuretics as well as ACE inhibitors. Therapy using ZORVOLEX in


patients with advanced renal disease isn't recommended.
2 Strand, V., et al., A New phase three Open-Label Trial associated with Low-Dose
Solumatrix Diclofenac in Patients together with Osteoarthritis Pain: Impact involving
Long-Term Administration upon Patient-Reported Outcomes. Poster
Presentation in American college associated with Rheumatology (ACR) 2014 Annual
Meeting.
"These outcomes add for the developing entire body involving knowledge pertaining to ZORVOLEX,
the lowest
dose treatment choice which is available nowadays for your management regarding
osteoarthritis pain," said Dr. Clarence Young, Chief medical Officer associated with
Iroko Pharmaceuticals.
ZORVOLEX should be used from the lowest effective dose for your shortest
duration consistent together with individual affected person therapy goals.
for much more information, visit www.ZORVOLEX.com.
Within the particular study, 299 (49.8%) patients that initially received ZORVOLEX 35mg
twice daily remained only from that dosing regimen and 302 (50.2%) patients
increased his or her ZORVOLEX dosage in order to 35mg three times daily at least once.
Twenty percent associated with patients whose dose had been increased coming from twice every
day to
three times daily subsequently underwent the dose reduction back for you to twice
daily2.
Gastrointestinal Risk
NSAIDs trigger an elevated risk of
serious gastrointestinal adverse events including bleeding, ulceration,
and also perforation of the stomach as well as intestines, which can be fatal. These types of
events could occur at virtually any time throughout use and also with out warning symptoms.

Elderly patients have reached higher danger for serious gastrointestinal


events.
With Regards To ZORVOLEX
ZORVOLEX has been developed for you to align along with
recommendations from FDA and also a amount of professional health-related organizations
in which NSAIDs end up being employed in the cheapest successful dose for that shortest
possible duration steady along with individual patient therapy goals.
ZORVOLEX can be the extremely first FDA-approved reduced dose NSAID developed using
proprietary SoluMatrix Fine Particle Technology(TM) and it is now available by
prescription. ZORVOLEX contains diclofenac as submicron particles in which
are approximately twenty occasions smaller than their own original size. Your
reduction within particle dimension provides a heightened surface area, leading
to become able to faster dissolution. Within September 2014, ZORVOLEX had been shortlisted inside
the particular best New Drug group for that 10th Annual SCRIP Awards, an award
which usually recognizes excellence throughout pharmaceutical development. for more
information, visit www.ZORVOLEX.com.
ZORVOLEX is actually contraindicated for the therapy of perioperative pain
within the environment regarding coronary artery bypass graft (CABG) surgery.
Concomitant administration regarding diclofenac and aspirin or even anticoagulants
just isn't usually advised simply because with the chance of increased GI
bleeding that's higher than within customers associated with either drug alone.
starting with 30 weeks' gestation, ZORVOLEX as well as other NSAIDs ought for you to be
avoided through pregnant females as premature closure in the ductus arteriosus
inside the fetus may occur.
one Altman, R., et al., Safety regarding Solumatrix Diclofenac within
Adults along with Osteoarthritis: results of your 12-Month, Cycle 3 Study. Poster

Presentation with American School of Rheumatology (ACR) 2014 Annual


Meeting.
the vast majority regarding adverse events inside the study had been mild for you to reasonable in
severity. Your many frequently reported adverse events included upper
respiratory tract infection (47/601, 7.8%), headache (46/601, 7.7%) as well as
urinary tract infection (44/601, 7.3%). Myocardial infarction was
reported throughout a couple of patients along with wasn't considered related to study
medication. Gastrointestinal ulcer was reported in any single patient1.
These kinds of data offer long-term safety info about the use of ZORVOLEX
throughout patients using osteoarthritis, a disorder related using chronic
pain.

With Regards To Iroko Pharmaceuticals, LLC


Iroko can always be a global specialty
pharmaceutical company, located in Philadelphia,
dedicated for you to advancing
the actual science involving analgesia. Your company
develops along with globally
commercializes pharmaceutical products. Iroko is at
the particular forefront with the
progression of SoluMatrix NSAIDs - new reduced
dose drug items according to
active NSAIDs - utilizing iCeutica Inc.'s proprietary SoluMatrix Fine
Particle Technology(TM) exclusively licensed in order to Iroko pertaining to NSAIDs. ZORVOLEX
can be the first SoluMatrix NSAID and is available in pharmacies; any 2nd
has been approved simply by FDA inside February 2014. Regarding more information, visit
www.iroko.com.
ZORVOLEX capsules 35mg twice or even 3 times daily were related using

improved HRQOL within patients using osteoarthritis pain. Patients receiving


ZORVOLEX reported clinically meaningful improvement (>=5) inside the Bodily
Element Score across the 52-week dosing period2. Your short
Form-36(TM) (SF-36v2) is really a health-related, patient-reported outcomes tool
which assesses physical along with mental domains.
ZORVOLEX capsules do not really bring about an equivalent systemic coverage to become able to
diclofenac as various other oral formulations. Therefore, do not substitute
similar dosing strengths associated with various other diclofenac products pertaining to ZORVOLEX.
important Safety Info about ZORVOLEX
NSAIDs could cause serious skin adverse events like exfoliative
dermatitis, Stevens - Johnson Syndrome (SJS), and also toxic epidermal
necrolysis (TEN), which can be fatal. ZORVOLEX needs to end up being able to be discontinued if
rash or other indications of nearby skin response occur.
Please notice total Prescribing
Details pertaining to extra important safety along with dosing
information.
Fluid retention and also edema happen for you to be observed in some patients taking
NSAIDs. ZORVOLEX ought to become able to be employed along with caution in patients together
with fluid
retention as well as heart failure.
The Actual 12-month, open-label, multicenter, Cycle 3 study evaluated ZORVOLEX
within 601 patients using knee or perhaps hip osteoarthritis have been chronic NSAID
or perhaps acetaminophen users. The Particular vast majority associated with patients were women
(372/601,
61.9%); patients ranged through 40 for you to 86 years of age; 45 % regarding
patients had been older when compared with 601. Patients initially received
ZORVOLEX 35mg twice daily, although your dosing routine could be

increased to end up being able to three times every day if necessary, and also subsequently reduced
as
needed2.
ZORVOLEX can be indicated for your management of mild in order to reasonable acute
pain along with osteoarthritis pain.
Elevation of 1 or more liver exams may occur in your course of therapy using
ZORVOLEX. Physicians should measure transaminases (ALT as well as AST)
periodically inside patients receiving long-term therapy with ZORVOLEX.
ZORVOLEX needs to always be able to be discontinued right away if abnormal liver assessments
persist or even worsen.
Cardiovascular Risk
Nonsteroidal anti-inflammatory drugs
(NSAIDs) may cause a heightened likelihood of serious cardiovascular
thrombotic events, myocardial infarction, as well as stroke, which can be fatal.
This particular risk may improve together with duration associated with use. Patients along with
cardiovascular disease or perhaps risk factors pertaining to cardiovascular disease may always be
at greater risk.
Anaphylactoid reactions might occur in patients with the aspirin triad as well as
throughout patients with out prior exposure to ZORVOLEX and may be
discontinued right away if an anaphylactoid reaction occurs.
most typical adverse reactions inside clinical trials (incidence >=2%)
include: edema, nausea, headache, dizziness, vomiting, constipation,
pruritus, diarrhea, flatulence, pain within extremity, abdominal pain,
sinusitis, alanine aminotransferase increased, blood creatinine
increased, hypertension, and dyspepsia.
ZORVOLEX is contraindicated inside patients with: any identified hypersensitivity

for you to diclofenac as well as its inactive ingredients; a reputation asthma,


urticaria, or other allergic-type reactions right after using aspirin or even
various other NSAIDs.

NSAIDs, including ZORVOLEX, can easily lead to the new onset or perhaps worsening involving
current hypertension, which might contribute to the increased incidence
involving cardiovascular events. Blood pressure ought in order to be monitored closely
throughout treatment along with ZORVOLEX. NSAIDs may diminish the antihypertensive
activity of thiazides, loop diuretics, ACE inhibitors and also angiotensin II
antagonists.
SoluMatrix can be a trademark associated with iCeutica Pty Ltd and is licensed for you to Iroko.