Burlington, MA-based Flexion Therapeutics in February released phase 3 data for its lead product candidate Zilretta, a novel nonopioid injectable for knee osteoarthritis (OA).
The sustained-release corticosteroid achieved the study’s primary endpoints, reducing pain 50% from baseline at 12 weeks in patients with moderate to severe knee OA pain, and reducing pain significantly at weeks one through 16 compared with placebo. It also achieved a secondary measure, statistical significance against placebo and immediate-release triamcinolone acetonide for pain, stiffness, and function through week 12.
Flexion plans to present detailed results from the phase 3 trial at an upcoming scientific meeting, according to the company.
The Food and Drug Administration fast tracked Zilretta last year, and the company’s planned NDA (new drug application) submission is on track for 2016. If approved, the therapy would be the first sustained-release corticosteroid injection for knee OA and the first new injectable approved for the condition in more than a decade.