Flexion Therapeutics Announces Publication of Results from Pivotal Phase 3 Study of ZILRETTA

Flexion Therapeutics (Nasdaq:FLXN) today announced that the key results from the previously completed pivotal Phase 3 study evaluating ZILRETTA (triamcinolone acetonide extended-release injectable suspension) have been published in the print and online edition of the Journal of Bone and Joint Surgery (Vol 100 (8) pp 666 – 677). ZILRETTA was approved by the U.S. Food and Drug Administration (FDA) on October 6, 2017, as an intra-articular (IA) injection for the management of pain associated with osteoarthritis (OA) of the knee.

As quoted in the press release:

The randomized, double-blind, placebo-controlled, active-comparator Phase 3 trial enrolled 484 patients at 37 centers worldwide. Patients were randomized to one of three treatment groups (1:1:1) and received either a single IA injection of ZILRETTA (32 mg), normal saline-placebo or triamcinolone acetonide in crystalline suspension (TAcs) (40 mg). Data from this study served as the foundation for ZILRETTA’s New Drug Application and subsequent FDA approval.

“These data demonstrate ZILRETTA’s ability to provide rapid, substantial and persistent pain relief in individuals with knee OA,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “The publication of these results in the prestigious Journal of Bone and Joint Surgery helps advance the dialogue within the medical and scientific communities about the important role ZILRETTA can play in the treatment paradigm of OA knee pain, presenting an important option for the millions of Americans who confront this painful disease.”

Click here to read the full press release.