Efficacy demonstrated in placebo-controlled trials¹⁰	YES
Efficacy demonstrated in a controlled US study (met primary efficacy end point with statistical significance)¹⁰	YES
Efficacy demonstrated in the largest US controlled study of any hyaluronan¹⁰^,^30-31	YES
Individual study results demonstrate efficacy (ie, no pooling of data required to show statistical difference)¹⁰	YES
Demonstrated efficacy with 5-injection and 3-injection regimens^*8^,¹¹	YES
Demonstrated 3 injection efficacy in 3 placebo controlled trials^*10^,^30-31	YES

Demonstrated efficacy versus active comparators in multiple clinical trials⁸^,¹⁴^,^35-36
100 published studies¹⁷

*Some patients may experience benefit with 3 injections given at weekly intervals. This has been noted in studies of patients receiving 3 injections who were followed for 60 days.¹⁰

Efficacy data

Important Safety Information for HYALGAN®

HYALGAN® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpha-rmacologic therapy, and to simple analgesics, eg, acetaminophen
HYALGAN® is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Intra-articular injections are contraindicated in cases of past and present infections or skin diseases in the area of the injection site
The effectiveness of a single treatment cycle of less than 3 injections has not been established
In the US clinical trial of 495 patients, the only adverse event showing statistical significance vs placebo was injection-site pain
Other adverse events included gastrointestinal complaints, headache, local ecchymosis and rash, local joint pain and swelling, and local pruritus. However, the incidence of these events was similar in the HYALGAN®-treated and placebo groups
In other clinical studies, the frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle

Click here for additional important information for HYALGAN®.