Genzyme Corporation (CAMBRIDGE, Massachusetts) announced preliminary results from a study conducted in Europe that indicate that patients treated with a single dose of Synvisc® (hylan G-F 20) achieved a statistically significant improvement in pain from osteoarthritis (OA) of the knee over 26 weeks compared with those using placebo. Currently, Synvisc is delivered through three intra-articular administrations given at 1-week intervals.

The prospective, double-blinded, 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 (Western Ontario and McMaster Universities Osteoarthritis Index), a scale for the measurement of OA pain. 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 US and Europe to include a one-injection regimen.

Genzyme will prepare the full set of data for publication in 2007 and presentation at upcoming orthopaedics and rheumatology conferences.

Manufactured and marketed by the Genzyme Biosurgery division of Genzyme, 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 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 OA in the knee and hip, and has recently received approval in Europe for the ankle and shoulder indications.

—A. Techman

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