FDA approves update of the product label for Zilretta for treatment of osteoarthritis knee pain.- Flexion Therapeutics

Flexion Therapeutics, Inc. announced that the FDA has approved a supplemental New Drug Application (sNDA) to update the product label for Zilretta (triamcinolone acetonide extended-release injectable suspension) for the treatment of osteoarthritis (OA) knee pain. Key elements of the label update include: Removal of language which stated that Zilretta was “not intended for repeat administration.” The updated label states that the “efficacy and safety of repeat administration of Zilretta have not been demonstrated.” Inclusion of a study description and safety data from the single-arm, open-label Phase III repeat administration trial. Removal of a misleading statement describing a single secondary exploratory endpoint in the original Phase III pivotal trial which compared Zilretta to immediate release triamcinolone acetonide crystalline suspension. Inclusion of nonclinical toxicology data from previously submitted single and repeat administration studies in non-diseased animals.