FDA nod for Smith & Nephew's amended label for Supartz Joint Fluid Therapy
The US FDA approved a label amendment for Supartz Joint Fluid Therapy of Smith & Nephew Trauma division. Although Supartz Joint Fluid Therapy is still indicated for five weekly injections, the amendment to the directions for use and the precaution section of the labelling now allow physicians to choose as few as three weekly injections for their patients with osteoarthritis knee pain if the physician judges the patients would experience benefit.
"Joint fluid therapy can provide relief for debilitating knee pain without drugs or surgery," Ken Reali, vice president and general manager for the Smith & Nephew Clinical Therapies division said adding, "This approval provides both doctors and patients with greater options and control over their treatment of osteoarthritis knee pain."
Joint Fluid Therapy is a treatment for osteoarthritic knee pain using intra-articular injections of hyaluronic acid. Supartz Joint Fluid Therapy was the first hyaluronan joint fluid therapy commercially available for human use in treating osteoarthritis (OA). It has a long clinical history with more than 150 million injections of Supartz Joint Fluid Therapy prescribed globally. It was approved in the US by the FDA in 2001.
"This is a significant benefit for my patients because I can now treat each patient individually with Supartz Joint Fluid Therapy, based on their osteoarthritis knee symptoms," said Dr. Orrin Troum of the Keck School of Medicine at the University of Southern California.
Today, as many as 20 million Americans suffer from knee OA, and that number is expected to increase with the aging population and rising obesity rates. By the age of 65, approximately 80% of Americans have some sign of OA. Increases in life expectancy and aging populations are expected to make it the fourth leading cause of disability by 2020.