Medscape Article:
March 5, 2009 — The US Food and Drug Administration (FDA) has approved long-acting formulation
of hylan G-F 20 for the treatment of pain related to osteoarthritis of the knee.
Longer-Lasting Formulation of Hylan G-F 20 (Synvisc-One) Approved for Knee Osteoarthritis
On February 26, the FDA granted marketing approval for a longer-lasting formulation of
hylan G-F 20 (Synvisc-One; Genzyme Corp), allowing its use for the treatment of pain related
to osteoarthritis of the knee in patients in whom adequate response to conservative over the counter
medications and simple analgesics has failed.
The product contains the same material and total treatment volume as the company's
3-injection viscosupplement (Synvisc), providing the 6 mL of hylan G-F 20 in a
single intraarticular injection.
"In just one visit to the doctor's office, patients suffering from osteoarthritis may experience
clinically significant pain relief for up to six months and for some patients this pain relief could
potentially translate into a delay in the need for a total knee replacement," said Jack M. Bert, MD,
in a company news release. "This single injection regimen will provide greater physician and patient
convenience." Dr. Bert is president of the Arthroscopy Association of North America and adjunct
clinical professor at the University of Minnesota School of Medicine.
Adverse events most commonly reported with product use were transient, mild to moderate arthralgia,
arthritis, arthropathy, injection site pain, and joint effusion. Patients should be advised to avoid
strenuous or prolonged weight-bearing activities for approximately 48 hours after treatment.
