Genzyme says one dose Synvisc best for arthritis

The preliminary research indicates that patients achieved a statistically significant improvement in pain from osteoarthritis of the knee over 26 weeks compared with those using placebo. Currently Synvisc is delivered through three intra-articular administrations given at one-week intervals.

The statistically significant findings of the primary endpoint were supported by a number of secondary outcomes, including a statistically significant treatment effect in favor of Synvisc in assessments completed by patients and their physicians of the severity of osteoarthritis symptoms. Analysis of the full set of secondary endpoints is ongoing.

“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,” said Ann Merrifield, president of the Genzyme Biosurgery division.

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 this type of administration.

Synvisc is indicated for the treatment of pain due to osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics.