Following an unblinded, pre-planned interim analysis, Tonix Pharmaceuticals has decided to stop enrollment in a phase 3 study evaluating cyclobenzaprine HCl sublingual tablets (TNX-102 SL) for the management of fibromyalgia.

The randomized, parallel-group, double-blind, placebo-controlled RALLY study (ClinicalTrials.gov Identifier: NCT04508621) is evaluating the efficacy and safety of TNX-102 SL in 514 adult patients with fibromyalgia. Patients were randomly assigned to receive either TNX-102 SL or placebo for 12 weeks. The primary endpoint was the change from baseline to week 14 in daily diary pain severity scores using the weekly averages of the daily numerical rating scale scores.

Based on interim analysis results of the first 337 enrolled participants, an independent data monitoring committee concluded that TNX-102 SL was unlikely to demonstrate a statistically significant improvement in pain compared with placebo. The decision to stop enrolling new patients was not related to the safety of TNX-102 SL.

The Company remains blinded to the detailed interim analysis and will continue to evaluate TNX-102 SL in the participants who are currently enrolled in the trial. “We are surprised and disappointed that the interim analysis did not support continued enrollment in this phase 3 RALLY study, especially considering the previous phase 3 RELIEF study, which had a similar design and achieved statistical significance on the primary endpoint,” said Seth Lederman, MD, President and CEO.


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Full analysis of the unblinded data is expected to be reported in the fourth quarter of 2021.

Reference

Tonix Pharmaceuticals announces outcome of interim analysis of phase 3 RALLY study of TNX-102 SL for the management of fibromyalgia. News 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-of-Interim-Analysis-of-Phase-3-RALLY-Study-of-TNX-102-SL-for-the-Management-of-Fibromyalgia.html.