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Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the launch of 1% Sodium Hyaluronate. The product received approval from the Center for Devices and Radiological Health of the U.S. Food and Drug Administration. 1% Sodium Hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) 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 Euflexxa®1 (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®.
“The launch of 1% Sodium Hyaluronate is a great example of using the expertise within Teva to bring together skills from both our generic and specialty business,” said Brendan O’Grady, EVP and Head of North America Commercial. “We are proud to bring an additional offering to the physicians and patients seeking treatment options for OA knee pain.”
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. For details on ordering call Teva Customer Service at 1-888-838-2872.
About 1% Sodium Hyaluronate
1% sodium hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen).
IMPORTANT SAFETY INFORMATION
Do not use 1% sodium hyaluronate to treat patients who have a known hypersensitivity to hyaluronan preparations. Do not use to treat patients with knee joint infections or to treat patients with infections or skin disease in the area of the injection site.
Do not concomitantly use disinfectants containing quaternary ammonium salts or chlorhexidine for skin preparations because hyaluronan can precipitate in their presence. Do not inject intravascularly because intravascular injections of 1% sodium hyaluronate may cause systemic adverse events.
The safety and effectiveness of 1% sodium hyaluronate has not been established in pregnant women. It is not known if 1% sodium hyaluronate is excreted in human milk. The safety and effectiveness of 1% sodium hyaluronate has not been established in lactating women or in children (21 years of age or younger).
The most common target-knee related treatment-emergent adverse event (TEAE) was arthralgia. The most common device-related and injection-related TEAE was injection site joint pain.
For more information, please see accompanying Full Prescribing Information. A copy may be requested from Teva US Medical Information at 888-TEVA-USA (888-838-2872), email@example.com, or Teva’s Public Relations or Investor Relations contacts.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 35,000 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch and potential benefits of 1% sodium hyaluronate which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2018, including the sections thereof captioned "Risk Factors." Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information.
1 Euflexxa is a registered trademark of Ferring BV
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Source: Teva Pharmaceutical Industries Ltd.