PHILADELPHIA, January 6, 2017 — Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today the receipt of a patent for VIVLODEX®(meloxicam) capsules 5 mg and 10 mg. The patent, issued by the United States Patent and Trademark Office (USPTO), will be listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication, or Orange Book, which includes all FDA-approved drugs, as well as patent and exclusivity information associated with this drug. The VIVLODEX® patent expires no earlier than 2033.
VIVLODEX®, a nonsteroidal anti-inflammatory drug (NSAID), is approved by the U.S. Food and Drug Administration (FDA) for the management of osteoarthritis pain in 5 mg and 10 mg doses administered once daily. VIVLODEX® is the first FDA-approved low dose SoluMatrix® meloxicam.
“This new patent reflects our fruitful collaboration with our partner, iCeutica, and the high quality work of our combined team,” said Osagie Imasogie, Chairman, Iroko Pharmaceuticals.
VIVLODEX is the first low-dose SoluMatrix® meloxicam approved for the management of osteoarthritis pain. VIVLODEX contains meloxicam 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 and rapid absorption. Low-dose SoluMatrix® NSAIDs were developed by Iroko to align with recommendations from FDA and other professional medical organizations that NSAIDs be used at the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. For more information, visit www.vivlodex.com.
VIVLODEX is a nonsteroidal anti-inflammatory drug indicated for the management of osteoarthritis pain.
Important Safety Information about VIVLODEX
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
VIVLODEX is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
VIVLODEX is contraindicated in patients with: a known hypersensitivity to meloxicam or its inactive ingredients; a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
VIVLODEX should be used at the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
Elevation of one or more liver tests may occur during therapy with VIVLODEX. Rare, sometimes fatal, cases of severe hepatic injury have been reported. VIVLODEX should be discontinued immediately if clinical signs and symptoms of liver disease develop.
NSAIDs, including VIVLODEX, can lead to the new onset or worsening of existing hypertension, which may contribute to the increased incidence of CV events. Blood pressure should be monitored during treatment with VIVLODEX. NSAIDs may diminish the antihypertensive activity of loop and thiazide diuretics, ACE inhibitors, angiotensin receptor blockers, or beta-blockers.
NSAID use has been associated with an increase in the risk of MI, hospitalizations due to heart failure, and death. Also, fluid retention and edema have been observed in patients taking NSAIDs. Avoid the use of VIVLODEX in patients with severe heart failure.
Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. VIVLODEX 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, dehydration, hypovolemia, and those taking diuretics and ACE inhibitors. Avoid the use of VIVLODEX in patients with advanced renal disease. Increases in serum potassium levels, including hyperkalemia, have been reported with NSAID use.
Anaphylactic reactions may occur in patients with the aspirin triad or in patients without prior exposure to VIVLODEX and should be discontinued immediately if an anaphylactic 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. VIVLODEX should be discontinued if rash or other signs of local skin reaction occur.
Starting at 30 weeks of gestation, VIVLODEX and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur.
Concomitant administration of anticoagulants, antiplatelet agents (e.g., aspirin), SSRIs, SNRIs, salicylates, or other NSAIDs with VIVLODEX may increase the risk of bleeding.
The anti-inflammatory and anti-pyretic activity of VIVLODEX may mask the signs of infection.
Since serious GI, hepatic, and renal events have been reported with NSAID use, consider monitoring CBC and chemistry profile in patients on long-term NSAID therapy.
Most common adverse reactions in clinical trials (incidence ≥2%) include: diarrhea, nausea, and abdominal discomfort.
VIVLODEX capsules do not result in an equivalent systemic exposure to other formulations of oral meloxicam. Therefore, do not substitute similar dosing strengths of other meloxicam products for VIVLODEX.
Please see full Prescribing Information for additional important safety and dosing information.
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. VIVLODEX is the third SoluMatrix® NSAID and is available in pharmacies; VIVLODEX is approved by FDA. 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.
SoluMatrix® is a trademark of iCeutica Pty Ltd and is licensed to Iroko.
VIVLODEX is a trademark of Iroko Pharmaceuticals, LLC.