Iroko said that a 12-week study Vivlodex delivered efficacy at low 5-mg and 10-mg doses in patients with osteoarthritis pain. The products dosage strengths (5 mg and 10 mg) are 33% lower than currently available oral meloxicam products, the global specialty pharmaceutical company noted.
Vivlodex has been approved by the Food and Drug Administration for the management of osteoarthritis pain.
“We are pleased to introduce Vivlodex, our third low dose SoluMatrix NSAID, and our second product for patients suffering from osteoarthritis pain,” stated 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 bleeds, are dose-related, Iroko reported. These NSAID-associated 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, the company said.
“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,” commented Clarence Young, chief medical officer for Iroko. “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.”