Flexion enrolls first patient in Phase 2 ZILRETTA study
Flexion Therapeutics announced the enrollment of the first patient in a clinical trial to evaluate the pharmacokinetics and safety of concurrent injections of ZILRETTA in patients with bilateral osteoarthritis of the knee. The randomized, open-label, Phase 2 study is expected to enroll approximately 24 patients. The safety and tolerability of a single injection of ZILRETTA has been established through multiple Phase 2 and Phase 3 clinical trials focused on administration in one knee. ZILRETTA received approval from the U.S. Food and Drug Administration on October 6, 2017 for the management of OA knee pain and the company initiated the full commercial launch on November 20, 2017. The study will compare plasma PK profiles after concurrent injections of ZILRETTA versus immediate-release triamcinolone acetonide in crystalline suspension. Patients will be randomized and treated with bilateral injections of either ZILRETTA or TAcs. Each patient will be evaluated for six weeks following injection. Flexion expects to report top-line results of the study in the first half of 2018.