Treat OA related knee pain! Flexion zilretta US label update!

December 27, 2019 / BIOON / -- flexion therapeutics is a biopharmaceutical company focusing on the development and commercialization of new and local therapies for musculoskeletal diseases Recently, the company announced that the US Food and Drug Administration (FDA) has approved a new drug supplement application (SNDA) to update the product label of zilretta (triamcinolone acetonide sustained release injection suspension) for the treatment of knee pain in osteoarthritis (OA) The key elements of label updating include: (1) deleting the wording of "cannot be used for repeated administration" of zilletta, and updating the label of "validity and safety of zilletta repeated administration have not been proved"; (2) including the research description and safety data of single arm and open label three-stage repeated administration trials; (3) deleting the single secondary level description in the original three-stage key trials Misleading statement of the end point of the study, which compared zilletta with the rapid release triamcinolone acetonide crystal suspension (4) Non clinical toxicological data from previously submitted single and repeated dose studies in non diseased animals were included Michael Clayman, President and CEO of flexion, said: "we are very satisfied with the label of the new product, because it has achieved the main goal of eliminating the unclear language of repeated administration, which we believe may be confusing for patients, doctors and payers In addition, we are satisfied with the inclusion of safety data for repeat drug trials and the deletion of inappropriate control statements We believe the updated label supports our goal that zilletta will become the first class intra-articular therapy for OA knee pain " John Richmond, M.D., director of network development medicine at New England Church Hospital, added: "as a clinician and a zilletta patient, I have first-hand experience that the drug can provide significant and lasting pain relief for patients facing knee osteoarthritis Zilletta is a valuable non opioid drug choice in the treatment of chronic OA knee pain It is very encouraging that the new product label can better provide information for clinical decision-making " In the United States, zilretta was approved by FDA on October 6, 2017, becoming the first and only slow-release intra-articular therapy for patients with knee pain related to osteoarthritis (OA) Using proprietary microsphere technology, zilretta combines triamcinolone acetonide, a commonly used short acting cortical sterol, with a polylactic acid hydroxyacetic acid (PLGA) matrix to provide long-term pain relief Key phase 3 trials supporting the approval of zilretta showed that zilretta significantly reduced knee pain within 12 weeks, with some patients experiencing pain relief for up to 16 weeks Osteoarthritis (OA), also known as degenerative arthritis, affects more than 30 million adults in the United States The prevalence of OA in the knee continues to rise due to age, obesity and sports injuries, and millions of OA patients receive intraarticular injection of corticosteroids or hyaluronic acid to treat knee pain every year Original source: flexion therapeutics announcements FDA app roval of SNDA to revise zilletta (triamcinolone acetonide extended release injectable suspension) product label