FDA Approves Zilretta NDA for Knee Osteoarthritis
Results showed that Zilretta demonstrated a highly significant reduction in average daily pain vs placebo at week 12.
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Zilretta (FX006; Flexion Therapeutics) for the treatment of patients with osteoarthritis (OA) of the knee.
The NDA submission was based on data from a randomized, double blind, placebo and active-comparator (immediate-release triamcinolone acetonide) controlled Phase 3 trial in 484 patients with OA of the knee. Results showed that Zilretta demonstrated a highly significant (P <.0001) reduction in average daily pain vs placebo at week 12 (primary endpoint), with durable and clinically meaningful pain relief in patients with moderate-to-severe OA knee pain. Additionally, Zilretta was found to have a tolerable safety profile, with no serious drug-related adverse events reported.
Zilretta is an intra-articular, extended-release formulation of triamcinolone acetonide in a poly lactic-co-glycolic acid (PLGA) co-polymer matrix. It is formulated using Flexion's proprietary microsphere technology to enhance and prolong the clinical effect of intra-articular corticosteroid treatment for OA knee pain.
The FDA has established a Prescription Drug User Fee Act (PDUFA) target action date of October 6, 2017 to make a decision on the NDA.
For more information visit Flexiontherapeutics.com.