Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, has announced that VIVLODEX™ (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID), is now available by prescription at pharmacies across the United States. In a 12-week study VIVLODEX delivered impressive efficacy at low 5-mg and 10-mg doses in patients with osteoarthritis (OA) pain. VIVLODEX dose strengths (5 and 10 mg) are 33% lower than currently available oral meloxicam products. VIVLODEX is approved by the U.S. Food and Drug Administration (FDA) for the management of osteoarthritis pain.1
"We are pleased to introduce VIVLODEX, our third low dose SoluMatrix® NSAID, and our second product for patients suffering from osteoarthritis pain," said Lou Vollmer, President and Chief Operating Officer of Iroko. "VIVLODEX now offers patients who are currently taking oral meloxicam an effective low-dose alternative that aligns with FDA prescribing recommendations to use the lowest effective dose of NSAIDs. The launch of VIVLODEX further strengthens our commitment to provide effective low-dose NSAID options for patients experiencing pain."
Systematic reviews of observational studies have shown that serious NSAID adverse events, including cardiovascular thrombotic events, myocardial infarction, stroke, gastrointestinal ulcers and gastrointestinal bleeds2-3 are dose related. These NSAID associated serious cardiovascular and gastrointestinal adverse events have prompted the FDA and professional medical organizations including the American Heart Association, American Gastroenterological Association, and The American College of Rheumatology, to recommend that NSAIDs be used at the lowest effective dose for the shortest possible duration.4-7
"VIVLODEX demonstrated significant pain relief at low 5 mg and 10 mg doses, and may present an important new treatment option for the 27 million Americans with osteoarthritis pain," said Dr. Clarence Young, Chief Medical Officer of Iroko Pharmaceuticals, LLC. "This latest launch provides patients living with osteoarthritis pain an efficacious, yet low dose, NSAID that aligns with recommendations by the FDA and leading professional organizations to use the lowest effective dose."
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.8 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 of time consistent with individual patient treatment goals. For more information, visit www.vivlodex.com.