A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

Phase 3 Completed 503 enrolled Tonix Pharmaceuticals, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.

Timeline

Start: 2019-12-09
Primary completion: 2020-10-29
Completion: 2020-10-29

Outcome

Met primary endpoint

registry analysis (superiority test); TNX-102 SL Tablets, 5.6 mg vs Placebo SL Tablet; p = 0.010; LS Mean Difference -0.4 (95% CI -0.7 to -0.1); Mixed Model Repeated Measures NCT04172831 ↗

paper Reduction in daily pain from baseline at week 14 was significantly greater with TNX-102 SL PMID 37165930 ↗

Publications

Lederman S, Arnold LM, Vaughn B, Kelley M, Sullivan GM. Efficacy and Safety of Sublingual Cyclobenzaprine for the Treatment of Fibromyalgia: Results From a Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Care Res (Hoboken). 2023 Nov;75(11):2359-2368. doi: 10.1002/acr.25142. Epub 2023 Jul 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	cyclobenzaprine	Unknown	5.6 mg	Other