Flexion Therapeutics announced that Zilretta (triamcinolone acetonide extended-release injectable suspension), the first extended-release, intra-articular injection for osteoarthritis knee pain, has been approved by the Food and Drug Administration (FDA).
Zilretta combines triamcinolone acetonide (TCA), a short-acting corticosteroid, with a poly lactic-co-glycolic acid (PLGA) matrix to provide pain relief over 12 weeks. TCA possesses anti-inflammatory and immunomodulating properties. It leads to activation of anti-inflammatory transcription factors (eg, lipocortins) and inhibition of inflammatory transduction pathways as it binds to the glucocorticoid receptor.
The FDA approval was based on data from a randomized, double-blind, Phase 3 clinical trial that included 486 patients at 37 centers. The participants were randomized 1:1:1 to receive either a single intra-articular injection of Zilretta 40mg, placebo or immediate-release TCA 40mg. The results found that Zilretta met its primary endpoint at Week 12 by providing highly significant, durable, and clinically meaningful pain relief vs. placebo (P<0.0001). Also, Zilretta demonstrated statistically significant analgesia vs. placebo at Weeks 1 to 16 with Zilretta-treated patients experiencing ~50% reduction in pain from baseline through Week 12.
“Healthcare providers are eager for new, non-opioid therapies that may help patients manage their osteoarthritis pain for extended periods of time,” said John Richmond, MD, of New England Baptist Hospital in a Flexion press release. “Zilretta gives us an important new non-surgical intervention.”
The Zilretta label also includes results from a parallel-group Phase 2 trial that found the treatment to be associated with a reduced blood glucose elevation in patients with OA and type 2 diabetes when compared with immediate release TCA.
Zilretta will be available as a 32mg strength injectable suspension in single-dose kits. It is anticipated to launch by late October.
For more information call (844) 353-9466 or visit Zilretta.com.