Data from Pharmawand - Curated by Marshall Pearce - Date added 11 January 2018
Flexion Therapeutics, Inc. announced initial findings from its ongoing Phase IIIb, open-label study to evaluate the repeat administration of Zilretta (triamcinolone acetonide extended-release injectable suspension) in patients with osteoarthritis (OA) of the knee. The data show that of the 205 evaluable patients enrolled in the study, 95% (195/205) experienced clinical benefit by Week 12 following the initial injection of Zilretta , as determined by self-assessment and with the agreement of their physician. Furthermore, to date 90% (176/195) of eligible patients have received a second dose of Zilretta between Weeks 12 and 24, with three patients still pending repeat administration. The primary endpoint of the trial is overall safety and general tolerability of repeat administration of Zilretta in patients with symptomatic OA of the knee. Participants received an initial intra-articular injection of Zilretta followed by evaluation at Weeks 12, 16, 20 or 24 to determine their eligibility for a second injection. Repeat administration occurred when, in the opinion of the patient and physician, the patient benefited from and tolerated the initial administration without safety concerns and was clinically indicated to receive additional treatment.
Participants who receive repeat administration of Zilretta are followed for a total of 52 weeks after the initial injection, regardless of when the second injection is administered. At specified times throughout the trial, participants undergo physical examinations, knee assessments and X-rays. To date, Zilretta has been well tolerated, no serious adverse events have been observed, and the overall safety profile is similar to that observed in the single injection pivotal Phase III trial. The full study results are expected in the third quarter of 2018.