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FDA Approves Zorvolex for Osteoarthritis Pain

Osteoarthritis PainOsteoarthritis, a degenerative joint disease, is associated with the breakdown of a joint’s cartilage. Managing the symptoms of the condition such as pain, stiffness and swelling is important to improve joint mobility and flexibility. Otherwise, joint pain and stiffness may become severe enough to make daily tasks difficult.

Being a chronic condition, OA is often treated with NSAIDs to manage the pain for an extended period of time. The U.S. Food and Drug Administration (FDA) recently approved Submicron Diclofenac (Zorvolex), a non-steroidal anti-inflammatory drug (NSAID) from Iroko Pharmaceuticals, for the management of osteoarthritis pain. NSAIDs may reduce inflammation and relieve pain. A new approach to pain management, Zorvolex is the first FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology™ and is now available by prescription.

Earlier in October 2013 this drug was approved by the FDA for the treatment of mild-to-moderate acute pain in adults. This medication contains diclofenac as submicron particles that are approximately 20 times smaller than their original size.

The approval of this drug for osteoarthritis pain management was supported by data from a 12-week, multi-center, randomized, double-blind, parallel-group, placebo-controlled trial that involved 305 patients, aged 41-90 years, with osteoarthritis of the hip or knee. Half of the patients were between the ages of 61-90. Participants were randomized to diclofenac 35mg three times daily, 35mg twice daily, or placebo.

Along with NSAIDS, other treatment approaches that reliable healthcare centers use to treat arthritis pain include – dietary supplements such as glucosamine and chondroitin sulfate, hyaluronic acid joint injections, anti-inflammatory diet, topical analgesics and electrotherapies – TENS units, IFC, and GS. Rehabilitation centers also offer different effective approaches for arthritis pain management such as – physical therapy, massage, and exercise programs.

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