Research & Development
Teva Launches 1% Sodium Hyaluronate in the United States
8 July 2019 - - Israeli drugmaker Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) has launched of 1% Sodium Hyaluronate, the company said.
The product received approval from the Center for Devices and Radiological Health of the US Food and Drug Administration.
1% Sodium Hyaluronate is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen).
The safety and effectiveness of 1% Sodium Hyaluronate was evaluated in a double-blind, prospective, multi-site, randomized, three-arm, parallel group, pivotal trial in adults.
The primary objective of the trial was to evaluate the effectiveness of three weekly intra-articular injections of 2 mL of 1% Sodium Hyaluronate into the knee as compared to placebo for the treatment of pain in subjects with OA.
The safety and effectiveness of 1% Sodium Hyaluronate was also compared with Euflexxa1 (1% sodium hyaluronate).
Individuals receiving 1% Sodium Hyaluronate reported a statistically significant decrease in pain scores from baseline to week 26 compared to individuals in the placebo group.
Overall, treatment-emergent adverse events were similar across all three study arms with the most common being pain in the knee or at the injection site. Effectiveness scores were similar between 1% Sodium Hyaluronate and Euflexxa.
1% Sodium Hyaluronate is supplied in a 3 mL disposable prefilled syringe containing 2 mL of 1% sodium hyaluronate, and packaged as three syringes to a carton.
1% sodium hyaluronate is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen).
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