Safety and efficacy
Genzyme's regulatory filing for CE mark of Synvisc-One was based on final data from a prospective, randomized, double-blind, placebo-controlled study that involved 253 patients at 21 sites across Europe. In this study, a statistically significant improvement in pain from osteoarthritis of the knee was observed over 26 weeks when compared to pain relief for patients receiving placebo treatment.
Statistically significant differences in favor of Synvisc-One were also observed in several secondary outcome measures of efficacy, including patient and clinician global assessments. The safety profile of Synvisc-One was no different from that of placebo; also, there was no increased risk of post- injection adverse reactions in the patients receiving a second injection of Synvisc-One six months after the first injection.
Data from the study were presented earlier this year at the European League Against Rheumatism annual meeting in Barcelona, Spain and have been accepted for a podium presentation at the American Association of Orthopaedic Surgeons annual meeting in March, 2008.
"Synvisc-One provides long-term pain relief for patients without the systemic safety risks associated with traditional OA therapies such as NSAIDs and COX2 inhibitors," stated Xavier Chevalier M.D., Head of Rheumatology, Hopital Henri Mondor, Creteil France. "This is a unique opportunity for physicians to treat patients with a single injection viscosupplement that offers a very good risk-benefit profile."
Synvisc is indicated for the treatment of pain due to osteoarthritis
(OA) of the knee in patients who have failed to respond adequately to
|SOURCE Genzyme Corp.|
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