Iroko Pharmaceuticals to Present Phase 3 VIVLODEX® Efficacy and Safety Data at World Congress of Osteoarthritis

PHILADELPHIA, March 31, 2016 – Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today that it will present two new analyses of data from the VIVLODEX® (meloxicam) capsules Phase 3 program. This includes an analysis from the first pivotal efficacy and safety study that supported US approval as well as the combined safety data from two Phase 3 studies. These analyses will be presented at the upcoming 2016 Osteoarthritis Research Society International (OARSI) World Congress on Osteoarthritis being held March 31-April 3 in Amsterdam, The Netherlands.

“We look forward to sharing new data about VIVLODEX, our third low dose SoluMatrix® NSAID and second treatment option for patients with osteoarthritis pain,” said Dr. Clarence Young, Chief Medical Officer, Iroko Pharmaceuticals, LLC. “VIVLODEX, and our portfolio of low dose NSAIDs were designed to provide patients and clinicians with options in line with recommendations by the FDA and leading professional organizations to use the lowest effective NSAID dose for the shortest possible duration.”

The presentations are:

Abstract Title: Low-Dose SoluMatrix Meloxicam Results in Clinically Meaningful Improvements in Pain in a Phase 3 Study of Patients with Osteoarthritis

Authors: Roy Altman, Marc Hochberg, Alan Kivitz, Allan Gibofsky, Daniel Solorio, and Clarence Young

Presentation Date & Time:

Poster Session 1
Friday, April 1, 2016
4:15 pm – 5:00 pm
Poster # 702

Poster Session 2
Saturday, April 2, 2016
4:15 pm – 5:00 pm
Poster # 702

Abstract Title: SoluMatrix Meloxicam Safety in Older Patients with Osteoarthritis Pain

Authors: Roy Altman, Marc Hochberg, Alan Kivitz, Allan Gibofsky, Daniel Solorio, Olaolu Imasogie, and Clarence Young

Presentation Date & Time:

Poster Session 1
Friday, April 1, 2016
3:30 pm – 4:15 pm
Poster # 317

Poster Session 2
Saturday, April 2, 2016
3:30 pm – 4:15 pm
Poster # 317

For more information, please visit the OARSI website.

About VIVLODEX

VIVLODEX is the first low-dose SoluMatrix® meloxicam approved for the management of osteoarthritis pain.1 VIVLODEX dose strengths (5 and 10 mg) are 33 percent lower than corresponding available oral meloxicam products. 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.2 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 dose for the shortest possible duration.

Iroko has entered into agreements to register, market and distribute VIVLODEX in 24 countries.

For more information, visit www.vivlodex.com.

VIVLODEX is a nonsteroidal anti-inflammatory drug indicated for the management of osteoarthritis pain in adults.

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.

 

1. Iroko Pharmaceuticals, LLC. Data on file.
2. Full Prescribing Information for VIVLODEX. 2015. Iroko Pharmaceuticals, LLC.