Flexion Therapeutics announced interim data from a Phase 3b, open-label study that evaluated the safety and tolerability of repeat administration of Zilretta (triamcinolone acetonide extended-release injectable suspension) in patients with osteoarthritis (OA) of the knee.
The new data, presented at the Osteoarthritis Research Society International (OARSI) 2018 World Congress, comes from a real-world study involving patients with knee OA, including those who were previously treated with intra-articular corticosteroids (51.9%).
Study patients received an initial injection of Zilretta with follow-up at Weeks 12, 16, 20 or 24 to determine eligibility for a second injection. Those who received the second injection were followed for a total of 52 weeks and underwent physical exams, knee assessments, and X-rays. The results showed that 74% of patients received a second injection of Zilretta between Weeks 16 and 24 (average time to second administration: 16.6 weeks).
Patients who received a repeat Zilretta injection experienced a 64% improvement in Western Ontario and McMaster Universities Arthritis Index (WOMAC)-A (pain), a 66% improvement in WOMAC-B (stiffness), a 64% improvement on WOMAC-C (function), and improvement represented by a doubling of the KOOS Quality of Life subscale score by Week 4. These effects were sustained in a substantial proportion of patients through Week 12. Full findings are anticipated in the third quarter of 2018.
Zilretta was approved in October 2017 as an intra-articular injection for patients with OA-related knee pain. It utilizes a proprietary microsphere technology combining triamcinolone acetonide with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief over 12 weeks.
For more information call (844) 353-9466 or visit Zilretta.com.