SYNVISC IMPROVES OSTEOARTHRITIS PAIN.
The prospective double-blind placebo-controlled study involved 253 patients at 21 sites in Europe. Patients were randomized to receive one six-milliliter dose of Synvisc or one six-milliliter dose of placebo (saline). In the primary endpoint, patients were evaluated over 26 weeks according to the WOMAC A scale, a validated and commonly used measurement of osteoarthritis pain.
The statistically significant findings of the primary endpoint were supported by a number of secondary outcomes, most notably a statistically significant treatment effect in favor of Synvisc in assessments completed by patients and their physicians of the severity of osteoarthritis symptoms. Both patients and physicians completing this assessment were blinded, meaning that they were unaware of whether the patient had received Synvisc or placebo. Analysis of the full set of secondary endpoints is ongoing.
In addition to the treatment advantage seen in the Synvisc group, preliminary data showed comparable safety information between the treatment and placebo arms.
"We are very encouraged by these results, which add to the growing body of evidence in support of Synvisc and reflect our commitment to continued innovation on behalf of patients and physicians," said Ann Merrifield, president of the Genzyme Biosurgery division. "We believe that delivering the benefits of Synvisc through one administration rather than three will provide additional options for physicians and patients that will reduce the cost and burden of multiple injections."
Genzyme will prepare the full set of data for publication in 2007 and presentation at upcoming orthopaedics and rheumatology conferences. Based on the results, Genzyme plans in the first half of 2007 to submit this new information to regulatory agencies and request an amendment to the Synvisc product label in the United States and Europe to include this type of administration.
These new data add to the growing clinical evidence that further supports Synvisc's use in treating the pain from osteoarthritis. Recently announced results from an independent investigator's clinical study found Synvisc to be superior in magnitude and duration of pain relief, functional improvement and patient satisfaction to another viscosupplementation product in treating patients with OA of the knee. These independent data were presented last June at the European League Against Rheumatism (EULAR) meeting in Amsterdam, The Netherlands, at the British Orthopaedic Association congress held last month in Glasgow, and at the American College of Rheumatology (ACR) meeting this month in Washington.
In addition to its efficacy in relieving OA knee pain, Synvisc, as a non-systemic treatment, has the advantage of avoiding some of the side effects associated with some non-steroidal anti-inflammatory drugs including the COX-2 inhibitors.
Synvisc is marketed in more than 60 countries and has been used to treat more than 3 million people.
Synvisc is indicated for the treatment of pain due to osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, for example, acetaminophen. Synvisc is currently approved in Europe and Canada to treat pain due to osteoarthritis in the knee and hip, and has recently received approval in Europe for the ankle and shoulder indications.
In clinical trials, the most commonly reported adverse events were transient local pain, swelling, and/or effusion in the injected knee. In some cases, these symptoms have been extensive. Other side effects such as rash have been reported rarely. Synvisc is contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections in or around the knee. Healthcare practitioners should exercise caution when using Synvisc in patients allergic to avian proteins, feathers, or egg products; who have evidence of venous or lymphatic stasis in the leg to be treated; or who have severe inflammation in the knee joint to be treated. Patients should be advised to avoid strenuous or prolonged weight-bearing activities after treatment. Strict adherence to aseptic technique must be followed to avoid joint infection. The safety and effectiveness of Synvisc in children and in pregnant or lactating women have not been established. It is unknown whether Synvisc is excreted in human milk.
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