Significant and long-lasting pain relief with 5-injection regimen

In the randomized controlled hyaluronate study conducted in the US (N=495) among patients with osteoarthritis (OA) of the knee…

HYALGAN® demonstrated long-lasting efficacy with a 5-injection regimen vs placebo1


US pivotal trial demonstrates long-lasting efficacy as effective as daily naproxen

  • One 5-injection cycle of HYALGAN® provided 6 months of pain relief equivalent to 364 doses of naproxen (500 mg bid), with fewer adverse events1

Study design

6-month, double-blind, placebo-controlled, US multicenter study (N=495) in patients ≥40 years with Kellgren grade 2 or 3 OA of the knee. The study compared intra-articular (IA) HYALGAN® 20 mg/wk X 5 with IA saline and 500 mg bid naproxen groups. All patients were allowed up to 4,000 mg/d for rescue analgesia (acetaminophen) as needed for pain.1

*
Mean pain score for completed patients during a 50-foot walk recorded on a 100-mm visual analog scale (VAS) adjusted for baseline severity (HYALGAN®, 54 mm; placebo, 55 mm).
†
At week 26, HYALGAN® was better than saline control for the mean difference in the pain scale adjusted for baseline severity.

Important Safety Information

HYALGAN is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Intra-articular injections are contraindicated in cases of present infections or skin diseases in the area of the injection site to reduce the potential for developing septic arthritis.

Transient increases in inflammation in the injected knee following HYALGAN injection have been reported in some patients with inflammatory arthritis such as rheumatoid arthritis or gouty arthritis. Physicians should evaluate whether HYALGAN treatment should be initiated when objective signs of inflammation are present.

The effectiveness of a single treatment cycle of less than 3 injections has not been established.

Patients should be advised to avoid any strenuous or prolonged weight-bearing activities within 48 hours following intra-articular injection.

Use caution when injecting HYALGAN into patients who are allergic to avian proteins, feathers and egg products.

Joint effusion, if present, should be removed prior to injection.

The safety and effectiveness of HYALGAN has not been established in children or in pregnant or lactating women. It is unknown whether HYALGAN is excreted in human milk.

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.

Indication

HYALGAN is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, eg, acetaminophen.

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