Flexion Therapeutics, Inc. presented results from an analysis that found patients treated in clinical trials of Zilretta (FX006), its lead candidate for the treatment of osteoarthritis (OA) knee pain, had a statistically significantly lower use of analgesic rescue medications following treatment compared to placebo. The data will be presented in a poster session (abstract #92) at PAINWeek 2017, the largest U.S. pain conference for frontline clinicians.
A post hoc, pooled analysis of three Phase 2/3 double-blind, randomized, placebo-controlled clinical trials was conducted with 586 patients suffering from OA of the knee. Patients received a single, intra-articular (IA) injection of Zilretta (32 mgs) or saline-placebo, and average daily pain (ADP) intensity was assessed for a period of at least 12 weeks. Trial participants received a rescue medication (acetaminophen/paracetamol 500 mg tablets) at the beginning of the study. The patients’ consumption of the rescue medication was monitored through a daily diary reporting system, and pill counts were confirmed at the clinical sites.
Rescue medications are commonly provided to patients in clinical trials investigating analgesic therapies. Patients can use rescue medicines to manage pain on an as-needed basis during the trial, and their utilization can provide investigators with important information about the overall analgesic effect of the therapy being studied.
The analysis showed that the use of rescue medication was statistically significantly lower (p<0.05) with Zilretta compared to saline-placebo at each of Weeks 1—12. At Week 12, the mean number of daily rescue medication tablets taken was 0.86 for Zilretta compared with 1.23 for saline-placebo, resulting in a least-square-mean (LSM) difference of -0.37. These results support the analgesic efficacy of Zilretta through 12 weeks post-IA injection. The incidence of adverse and serious adverse events were similar across the Zilretta and saline-placebo groups (51.9% vs 49.2%, and 3.1% vs 1.1%, respectively). No drug-related serious adverse events were observed in these trials and adverse events have typically been localized, mild and comparable to those observed with saline-placebo.
“In clinical trials, Zilretta has demonstrated clinically meaningful pain relief for patients with OA of the knee for at least 12 weeks, and the reduced utilization of rescue medicines observed in this analysis serves as another important indicator of the robustness of Zilretta’s analgesic profile,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “We believe that, pending regulatory approval, Zilretta has the potential to bring meaningful pain relief to millions of Americans who make up this large and growing patient population.”
Filed Under: Drug Discovery