FDA approves Flexion’s Zilretta product label update

Flexion Therapeutics (NASDAQ:FLXN) gets FDA approval for a supplemental New Drug Application to update the product label for Zilretta (triamcinolone acetonide extended-release injectable suspension) for the treatment of osteoarthritis knee pain.

Key parts of the label update include:

Removing language stating 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”;

Includes a study description and safety data from the single-arm, open-label Phase 3 repeat administration trial;

Removing a misleading statement describing a single secondary exploratory endpoint in the original Phase 3 pivotal trial which compared Zilretta to immediate release triamcinolone acetonide crystalline suspension; and

Includes nonclinical toxicology data from previously submitted single and repeat administration studies in non-diseased animals.

Conference call on Dec. 27 at 8:00 AM ET.

https://seekingalpha.com/news/3528510-fda-approves-flexions-zilretta-product-label-update