New Data Shows that VIVLODEX® Reduces Rescue Medication Use in Patients with Osteoarthritis Pain

PHILADELPHIA, May 12, 2016 /PRNewswire/ -- Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today that new data from a Phase 3 study in patients with osteoarthritis (OA) pain demonstrated patients treated with VIVLODEX^® (meloxicam) capsules consistently used less rescue pain medication, regardless of time of day, compared to patients receiving  placebo.

VIVLODEX is a low-dose SoluMatrix^® nonsteroidal anti-inflammatory drug (NSAID) that was approved by the U.S. Food and Drug Administration (FDA) in October 2015 for the management of osteoarthritis pain.¹ VIVLODEX dose strengths 5 and 10 mg are 33 percent lower than other currently available oral meloxicam products. 

Patients receiving VIVLODEX 5 mg and 10 mg used significantly less total rescue medication, took fewer daily doses of rescue medication and for fewer days compared with patients receiving placebo. The greatest benefits were seen in patients taking VIVLODEX 10 mg. Regardless of the time of day, patients receiving VIVLODEX 10 mg per day took about half as many rescue pain medication doses as patients receiving placebo.

"Effective pain medications generally require patients to use less rescue medication. Patients taking VIVLODEX 10 mg once daily in this study took the least amount of rescue medication," said Alan J. Kivitz, MD, CPI, President, Altoona Center for Clinical Research, and President, Altoona Arthritis and Osteoporosis Center. Dr. Kivitz is a co-author of the poster summarizing these data and was an investigator in the trial. "These data support the efficacy of once-daily VIVLODEX to manage OA pain."

The rescue medication data were captured in real-time using a novel application of the medication event monitoring system (MEMS). MEMS contain a microelectronic chip that registers the date and time of every bottle opening. Compared with current methods of assessing rescue medication use in clinical trials, such as pill counts and self-reported medication diaries, MEMS medication bottles can provide a potentially more reliable and robust measurement of rescue medication use over time.

"This innovative application of MEMS caps demonstrated persistence of efficacy for the full 24-hour dosing period, and provided support for a once-daily dose regimen of our low-dose VIVLODEX for millions of Americans with osteoarthritis pain," ² said Dr. Clarence Young, Chief Medical Officer of Iroko Pharmaceuticals, LLC. "Iroko is committed to providing patients with treatment options that align with recommendations from the FDA and several professional medical organizations to use NSAIDs at the lowest effective dosage for the shortest duration."

Study Design
This double-blind, multicenter placebo-controlled Phase 3 study enrolled 403 patients, who were chronic NSAID and/or acetaminophen users, with osteoarthritis of the knee or hip. Patients were randomized to receive either one of two doses of VIVLODEX once daily (5 mg or 10 mg) or placebo for 12 weeks. Rescue medication, acetaminophen 500 mg (every 4-6 hours as needed), was permitted and provided in bottles equipped with a MEMS cap that recorded bottle opening events. Rescue medication accountability (i.e., pill counts) was also performed.

Among the detailed findings of this study were:

1. Patients in the 10 mg (48.4) and 5 mg (52.4) groups received significantly fewer doses of rescue medication over 12-weeks than those in the placebo group (73.2).
2. The mean daily rescue medication dosage was significantly lower in the 10 mg group (313.6) and 5 mg (326.2) group compared to placebo (464.1).
3. The mean number of days with a rescue event was significantly less in the 10 mg group (23.5) and 5 mg (25.3) group compared to placebo (33.9).
4. A dose-related trend was observed in the average number of rescue events per patient over 12-weeks by time of day.
5. The average number of rescue events per patient over 12-weeks by time of day was as follows:

The results were presented today at the 35^th Annual Scientific Meeting of the American Pain Society in Austin, Texas. 

About VIVLODEX

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.

Contacts:

Caitlin Finnegan for Iroko Pharmaceuticals, LLC, 212-303-2321

Meg Kramer, Iroko Pharmaceuticals, LLC, 267-546-1656

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.

References:

1. Full Prescribing Information for VIVLODEX. 2015. Iroko Pharmaceuticals, LLC.
2. Neogi T. et al. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage, 2013 http://www.ncbi.nlm.nih.gov/pubmed/23973124.

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SOURCE Iroko Pharmaceuticals, LLC

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