Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company
dedicated to advancing the science of analgesia, today announced the
company affiliate's first regulatory submission outside of the United
States for ZORVOLEX® (diclofenac) capsules. A new drug application was
filed for the nonsteroidal anti-inflammatory drug (NSAID) with the
Republic of Lebanon Ministry of Public Health (MOPH). ZORVOLEX was
approved by the U.S. Food and Drug Administration (FDA) in October 2013
for the treatment of mild to moderate acute pain in adults and is not
currently approved for marketing in any other country. A supplemental
New Drug Application seeking approval for osteoarthritis pain is
currently being reviewed by FDA.
"The first ZORVOLEX filing outside of the United States is a tremendous
milestone for our company, building on a very busy first half of 2014,
which included the ZORVOLEX U.S. launch, FDA approval of our second low
dose NSAID and receipt of critical patents for both products," said
John Vavricka, President and CEO of Iroko Pharmaceuticals.
This filing was the result of a licensing agreement signed late last
year by the company's affiliate, Iroko Pharmaceuticals Inc., and
Algorithm S.A.L. under which Algorithm obtained the exclusive rights to
market and sell ZORVOLEX to countries in the Middle East and North
"We are pleased with this first milestone to come from our partnership
with Iroko and look forward to bringing this low dose NSAID option to
patients and prescribers throughout the MENA region," said Selim
Ghorayeb, CEO of Algorithm.
Iroko will continue to retain all marketing rights to ZORVOLEX in the
United States, and is in discussions with additional companies to bring
ZORVOLEX to other international markets. ZORVOLEX has been available in
U.S. pharmacies since January of this year, and has since seen
continuing growth in prescriptions.
"We are delighted to see the first fruits of our partnership with
Algorithm and are looking forward to expanding access to ZORVOLEX and
eventually, other products from our low dose SoluMatrix® NSAID
portfolio, across the MENA region and the rest of the world," said
Osagie Imasogie, Executive Chairman of the Board, Iroko Pharmaceuticals.
ZORVOLEX is the first low dose FDA-approved NSAID developed using
proprietary SoluMatrix Fine Particle Technology™ that is now available
by prescription. ZORVOLEX contains diclofenac as submicron particles
that are approximately 20 times smaller than their original size. The
reduction in particle size provides an increased surface area, leading
to faster dissolution. ZORVOLEX was developed to align with
recommendations from FDA and several professional medical organizations
that NSAIDs be used at the lowest effective dose for the shortest
possible duration consistent with individual patient treatment goals.
ZORVOLEX is not approved for the treatment of osteoarthritis pain. A
supplemental New Drug Application seeking approval for this indication
is currently being reviewed by FDA. For more information, visit www.ZORVOLEX.com.
ZORVOLEX is indicated for the treatment of mild to moderate acute
pain in adults.
Important Safety Information about ZORVOLEX
Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased
risk of serious cardiovascular thrombotic events, myocardial infarction,
and stroke, which can be fatal. This risk may increase with
duration of use. Patients with cardiovascular disease or risk
factors for cardiovascular disease may be at greater risk.
ZORVOLEX is contraindicated for the treatment of perioperative pain
in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including bleeding, ulceration, and perforation of the stomach or
intestines, which can be fatal. These events can occur at any
time during use and without warning symptoms. Elderly patients
are at greater risk for serious gastrointestinal events.
ZORVOLEX is contraindicated in patients with: a known hypersensitivity
to diclofenac or its inactive ingredients; a history of asthma,
urticaria, or other allergic-type reactions after taking aspirin or
ZORVOLEX should be used at the lowest effective dose for the shortest
duration consistent with individual patient treatment goals.
Elevation of one or more liver tests may occur during therapy with
ZORVOLEX. Physicians should measure transaminases (ALT and AST)
periodically in patients receiving long-term therapy with ZORVOLEX.
ZORVOLEX should be discontinued immediately if abnormal liver tests
persist or worsen.
NSAIDS, including ZORVOLEX, can lead to the new onset or worsening of
existing hypertension which may contribute to the increased incidence of
cardiovascular events. Blood pressure should be monitored closely during
treatment with ZORVOLEX. NSAIDs may diminish the antihypertensive
activity of thiazides, loop diuretics, ACE inhibitors and angiotensin II
Fluid retention and edema have been observed in some patients taking
NSAIDs. ZORVOLEX should be used with caution in patients with fluid
retention or heart failure.
Long-term administration of NSAIDs can result in renal papillary
necrosis and other renal injury. ZORVOLEX should be used with caution in
patients at greatest risk of this reaction, including the elderly, those
with impaired renal function, heart failure, liver dysfunction, and
those taking diuretics and ACE inhibitors.
Treatment with ZORVOLEX in patients with advanced renal disease is not
Anaphylactoid reactions may occur in patients with the aspirin triad or
in patients without prior exposure to ZORVOLEX and should be
discontinued immediately if an anaphylactoid reaction occurs.
NSAIDs can cause serious skin adverse events such as exfoliative
dermatitis, Stevens - Johnson Syndrome (SJS), and toxic epidermal
necrolysis (TEN), which can be fatal. ZORVOLEX should be discontinued if
rash or other signs of local skin reaction occur.
Starting at 30 weeks gestation, ZORVOLEX and other NSAIDs should be
avoided by pregnant women as premature closure of the ductus arteriosus
in the fetus may occur.
Concomitant administration of diclofenac and aspirin or anticoagulants
is not generally recommended because of the risk of increased GI
bleeding higher than users of either drug alone.
Most common adverse reactions in clinical trials (incidence =2%)
include: edema, nausea, headache, dizziness, vomiting, constipation,
pruritus, flatulence, pain in extremity, and dyspepsia.
ZORVOLEX capsules do not result in an equivalent systemic exposure to
diclofenac as other oral formulations. Therefore, do not substitute
similar dosing strengths of other diclofenac products for ZORVOLEX.
Please see full Prescribing
Information for additional important safety and dosing
About Algorithm S.A.L.
Algorithm, a Lebanon-based pharmaceutical manufacturer, is actively
present in the MENA region and Cyprus. Algorithm is dedicated to
offering quality products, either under license from reputable
international companies or developed by the company's product
development team. The portfolio consists of innovative products as well
as differentiated generics, focusing mainly on the following therapeutic
areas: Cardiometabolic Diseases, Ortho-Rheumatology, Neurology,
Onco-Hematology, Endocrinology, Uro-Gynecology, and Dermatology. For
more information, visit www.algorithm-lb.com/en_Home.
About Iroko Pharmaceuticals, LLC
Iroko is a global specialty pharmaceutical company, based in
Philadelphia, dedicated to advancing the science of analgesia. The
company develops and globally commercializes pharmaceutical products. In
addition to the Iroko products that are marketed worldwide, the company
has a robust pipeline of investigational low dose NSAID products being
developed using iCeutica Inc.'s proprietary SoluMatrix Fine Particle
Technology™. For more information, visit www.iroko.com.
SoluMatrix Fine Particle Technology™ is a trademark of iCeutica Inc.,
and the technology is licensed to Iroko for exclusive use in NSAIDs.
SoluMatrix® is a trademark of iCeutica Pty Ltd and is licensed to Iroko.
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