BURLINGTON, Mass., Nov. 01, 2016 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today reported top-line results from a clinical trial to assess the effects of its investigational lead drug candidate, Zilretta (also known as FX006), on blood glucose levels in adults with osteoarthritis (OA) of the knee who also have Type 2 diabetes. Results from the trial demonstrated Zilretta is associated with a statistically significant (p<0.05, 2-sided) and clinically relevant reduction in the rise of blood glucose compared to that observed following immediate-release (IR) triamcinolone acetonide (TCA) injection in patients who also have knee OA. Zilretta has previously demonstrated clinically meaningful improvement of pain, stiffness and function in its Phase 3 pivotal trial in patients with knee OA.
The objective of the double-blind, randomized, parallel group, single-dose study was to examine if Zilretta had effects on blood glucose levels that differ from IR TCA. Investigators from seven study sites enrolled 33 patients, randomized 1:1 to receive a single intra-articular injection of 40 mg Zilretta or 40 mg IR TCA. Blood glucose levels were evaluated for a total of 3 weeks (one week prior to injection and two weeks post injection) using a continuous glucose monitoring device. Patients returned for follow up visits at Day 8, Day 15 and Week 6/Day 43. The primary endpoint compared the change in average glucose values from the period of 72 hours before to the period 72 hours after injection with Zilretta versus IR TCA.
"It is well-known that immediate-release corticosteroids can cause substantial elevations in blood glucose among patients with diabetes following an intra-articular injection, an effect that is likely tied to peak plasma concentrations. Because pharmacokinetic studies have shown that Zilretta is associated with much lower peak plasma concentrations, we hypothesized that any rise in glucose after a Zilretta injection would be negligible. The data are consistent with this hypothesis and we are enthusiastically looking forward to presenting the detailed study results at an upcoming scientific forum," said Michael Clayman, M.D., Flexion Therapeutics' President and Chief Executive Officer. "We believe these data demonstrate that Zilretta may limit effects on blood glucose which, if approved, could have future implications for the many knee OA patients in the U.S. who also have Type 2 diabetes. We look forward to including these topline data in the Zilretta new drug application (NDA) which we plan to submit by the end of the year."
