The presentation, “TNX-102 SL for the Treatment of Fibromyalgia: Comparison of 30% Pain Responder Analysis with OMERACT Draft Composite Responder Endpoint Analyses,” revealed the drug could reduce pain and improve sleep in fibromyalgia (FM) patients.
TNX-102 SL (cyclobenzaprine HCl) acts against several receptors in pain, sleep and stress such as serotonin-2A, alpha-1 adrenergic, and histamine H1. Tonix’s Phase 2b clinical trial, called Bestfit, recruited 205 randomized patients who received TNX-102 SL (103 patients) or placebo (102 patients) for 12 weeks. Patients took the tablets at bedtime under the tongue.
The study indicated 30% or higher experienced less pain and more physical function and sleep quality according to criteria by the Outcome Measures in Rheumatology. A long version of reporting put results at up to 30% improvement in two of any of the following symptoms: sleep, fatigue, depression, anxiety, or cognition.
The study concluded that 30% of the patients treated with TNX-102 SL reported a reduction in pain compared to 20.6% of those who received placebo. Most of the side effects, such as drowsiness, dry mouth, back pain, nausea and sinusitis, were similar to placebo. However, mouth numbness was markedly more common in patients taking TNX-102 SL (44% versus 2%).
Tonix is now conducting a double-blind, placebo-controlled Phase 3 clinical trial, called Affirm, in a larger number of patients. Data is expected in the third quarter of 2016, and an application will be submitted to the U.S. Food and Drug Administration for approval.
Seth Lederman, chairman and CEO of Tonix, said TNX-102 SL “clearly demonstrates improvements in the key domains of fibromyalgia,” confirmed through testing.
“Given that, we are very pleased with the results from this analysis as it gives us further confidence as we look forward to the outcome of our ongoing Phase 3 study. Most importantly, we believe Tonix will have the potential to provide a meaningful treatment alternative to fibromyalgia patients,” Lederman said.