Following a non-blinded, pre-planned interim analysis, Tonix Pharmaceuticals has decided to discontinue participation in a phase 3 study evaluating cyclobenzaprine HCl sublingual tablets (TNX-102 SL) for the treatment of fibromyalgia.
The randomized, double-blind, placebo-controlled, parallel-group study RALLY (ClinicalTrials.gov Identifier: NCT04508621) examines the efficacy and safety of TNX-102 SL in 514 adult patients with fibromyalgia. Patients were randomized to receive either TNX-102 SL or placebo for 12 weeks. The primary endpoint was the change in diary daily pain severity scores from baseline to week 14 using the weekly averages of the daily numerical rating scale scores.
Based on the results of the interim analysis of the first 337 enrolled participants, an independent data monitoring committee concluded that TNX-102 SL was unlikely to show a statistically significant improvement in pain compared to placebo. The decision to discontinue admitting new patients was not related to the safety of the TNX-102 SL.
The company remains blind to the detailed interim analysis and will continue to evaluate TNX-102 SL with the participants currently enrolled in the study. “We are surprised and disappointed that the interim analysis does not support further inclusion in this phase 3 RALLY study, especially in view of the previous phase 3 study RELIEF, which had a similar design and achieved statistical significance for the primary endpoint” said Seth Lederman, MD, President and CEO.
The full analysis of the open-ended data is expected to be released in the fourth quarter of 2021.
Tonix Pharmaceuticals announces the results of the interim analysis of the Phase 3 RALLY study of TNX-102 SL for the treatment of fibromyalgia. Press release. Tonix Pharmaceuticals Holding Corp. July 23, 2021. Accessed July 26, 2021. https://www.globenewswire.com/news-release/2021/07/23/2268197/28908/en/Tonix-Pharmaceuticals-Announces-Outcome- von-Zwischenanalyse- the-Phase-3-RALLY-Study-of-TNX-102-SL-for-the-Management-of-Fibromyalgia.html.
This article originally appeared on Clinical Pain Advisor
Chronic Pain Fibromyalgia Pain Treatments