Genzyme Corp (CAMBRIDGE, Massachusetts) announced filing with the US FDA for product marketing authorization (PMA) of Synvisc-Oneâ„¢, the single treatment combining three doses of Synvisc® (hylan G-F 20) that provides up to 6 months of pain relief from osteoarthritis (OA) of the knee. If approved, Synvisc-One would be the only viscosupplementation product available worldwide proven to provide this duration of pain relief from a single injection. The company expects FDA authorization by the end of the year. Submission of these data to obtain a CE mark for Synvisc-One in Europe is expected to occur in July.

Genzyme's regulatory filing for Synvisc-One is based on final data from a prospective, randomized, double-blind, placebo-controlled study involving 253 patients at 21 sites across Europe, which demonstrated that the single treatment provides 6 months' safe and effective pain relief in patients with OA of the knee. Patients in the study were randomized to receive either one 6-mL treatment of Synvisc or one 6-mL injection of placebo (saline). The primary endpoint evaluated patients for longer than 6 months using the WOMAC A pain scale. For the treatment group, these data resulted in statistically significant improvement in pain relief from knee OA compared with relief for patients in the placebo group. Data from the study also showed that Synvisc-One demonstrated a 36% reduction in pain over 26 weeks as compared to baseline.

The statistically significant findings were supported by a number of secondary outcomes, most notably a statistically significant treatment effect in favor of Synvisc-One in double-blind assessments of the severity of knee OA symptoms completed by patients and their physicians. Data showed comparable safety information between the treatment and placebo arms.

Genzyme Biosurgery, the business unit of Genzyme Corp, manufactures and markets Synvisc in the US, where it is indicated for the treatment of pain caused by OA of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, such as acetaminophen. In Europe and Canada, Synvisc is currently approved to treat pain caused by OA in the knee and hip, and it is also approved in Europe in ankle and shoulder indications. The only other single-treatment viscosupplement available in Europe offers only 6 weeks of pain relief.

Synvisc is the market-leading viscosupplementation product in the US, and has been used to treat more than 3 million people worldwide. Synvisc is currently delivered through three intra-articular administrations of 2 mL each given at 1-week intervals.

—A. Techman

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