Tonix Pharmaceuticals publishes results from RESILIENT trial in Pain Medicine

Tonix Pharmaceuticals (TNXP) announced that full results from its confirmatory Phase 3 RESILIENT trial of TNX-102 SL for the management of fibromyalgia have been published online in the peer reviewed Pain Medicine, the official journal of the American Academy of Pain Medicine. The publication is titled, “Pain Relief by Targeting Nonrestorative Sleep in Fibromyalgia: A Phase 3 Randomized Trial of Bedtime Sublingual Cyclobenzaprine”. RESILIENT was a randomized, double-blind, placebo-controlled trial that enrolled 457 adults with fibromyalgia across 33 United States sites. Participants received TNX-102 SL 2.8 mg for two weeks followed by 5.6 mg for twelve weeks, or matching placebo, with efficacy assessed over fourteen weeks. Treatment with TNX-102 SL produced a least-squares mean reduction of 1.8 points on the eleven-point daily pain numeric rating scale compared with a 1.2-point reduction for placebo, achieving the primary endpoint with high statistical significance. Statistically significant improvements were also observed across all six prespecified key secondary endpoints, including Patient Global Impression of Change responder analysis, Fibromyalgia Impact Questionnaire – Revised Symptoms and Function domains, and the PROMIS Sleep Disturbance and Fatigue instruments. TNX-102 SL was generally well tolerated. The most common treatment-emergent adverse events were oral tingling/numbness and bitter or noticeable aftertaste, which were typically mild, transient lasting less than an hour, and self-limiting. No drug-related serious adverse events or deaths were reported. These safety and efficacy findings underscore TNX-102 SL’s favorable risk-benefit profile and its potential to address the unmet needs of people living with fibromyalgia.