PHILADELPHIA, PA – December 7, 2016 – Iroko Pharmaceuticals LLC, a global specialty pharmaceutical company, dedicated to advancing the science of analgesia, today provided an update in relation to its novel ZORVOLEX® Capsules 18 mg and 35 mg. Iroko has been advised that the United States Food and Drug Administration (FDA) has tentatively approved Lupin Pharmaceuticals, Inc.’s, Abbreviated New Drug Application (ANDA) for its Diclofenac Capsules, 18 mg and 35 mg to market a generic version of Iroko’s, ZORVOLEX® Capsules 18 mg and 35 mg.
The approval from the FDA is tentative and therefore does not impact Iroko’s current business or the continued sales and marketing strategies of ZORVOLEX®. Iroko has and will continue to vigorously defend the several patents and regulatory rights that protect ZORVOLEX®. To this end, Iroko and iCeutica Pty Ltd, its licensor of the SoluMatrix Fine Particle Technology™ platform, have brought a Paragraph IV law suit against Lupin alleging the infringement of Iroko’s patents protecting the ZORVOLEX® products.
Under the Drug Price Competition and Patent Term Restoration Act (“Hatch Waxman”), FDA final approval, which Lupin will require in order to begin marketing their product, cannot occur until the earlier of the resolution of the Paragraph IV law suit or the 30 month statutory stay, which expires in May 2017. Additionally, ZORVOLEX® has US regulatory market exclusivity for the management of osteoarthritis pain until August 2017. Iroko is committed to defending the IP protecting ZORVOLEX® to the fullest extent of the law.
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 the first FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology™ and is now available by prescription. ZORVOLEX contains diclofenac as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. In 2014, ZORVOLEX was shortlisted in the Best New Drug category for the 10th Annual SCRIP Awards, an award which recognizes excellence in pharmaceutical development. For more information, visit www.ZORVOLEX.com.
ZORVOLEX is indicated for the management of mild to moderate acute pain and osteoarthritis pain.
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 other NSAIDs.
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 antagonists.
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 recommended.
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 that is higher than in users of either drug alone.
Most common adverse reactions in clinical trials (incidence ≥2%) include: edema, nausea, headache, dizziness, vomiting, constipation, pruritus, diarrhea, flatulence, pain in extremity, abdominal pain, sinusitis, alanine aminotransferase increased, blood creatinine increased, hypertension, 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 information.
For more information, visit www.ZORVOLEX.com.
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. Iroko is at the forefront of the development of SoluMatrix® NSAIDs – new low-dose drug products based on existing NSAIDs – using iCeutica Inc.’s proprietary SoluMatrix Fine Particle Technology™ exclusively licensed to Iroko for NSAIDs. For more information, visit www.iroko.com.
Lindsay Gordon for Iroko Pharmaceuticals, LLC – 267-546-1480
SoluMatrix Fine Particle Technology™ is a trademark of iCeutica Inc., and the technology is licensed to Iroko for exclusive use in NSAIDs.