Tonix Pharma to Present TNX-102 SL Posters at ASCP Annual Meeting

Tonix Pharmaceuticals, Inc., a comprehensive biopharmaceutical company, has recently shared findings and updates on TNX-102 SL, a sublingual formulation of cyclobenzaprine. This medication is being explored in multiple trials for its potential to treat various conditions, including fibromyalgia-type Long COVID and Acute Stress Disorder (ASD) stemming from traumatic events such as motor vehicle collisions.

During the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting from May 28-31, 2024, Tonix unveiled two significant poster presentations. The first study, titled “Effect of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) on Pain, Sleep, Fatigue, and Cognition in Fibromyalgia-Type Long COVID,” highlighted the results of a double-blind, randomized Phase 2 trial. This research demonstrated that TNX-102 SL significantly improved fatigue and showed consistent benefits across secondary measures including sleep quality, cognitive function, disability, and overall patient impression of change, despite not achieving the primary goal of reducing multi-site pain by the 14th week. The effect sizes for crucial endpoints such as sleep quality, fatigue, and cognitive function met pre-specified criteria for further investigation, suggesting promising areas for additional research. Moreover, TNX-102 SL was well tolerated without any new safety concerns.

Seth Lederman, M.D., Tonix’s CEO, emphasized that these results support the theory that Long COVID symptoms may be driven by central nervous system mechanisms rather than ongoing exposure to the SARS-CoV-2 virus. He indicated that while Tonix is gearing up to submit a New Drug Application (NDA) for TNX-102 SL, branded as Tonmya, for managing fibromyalgia, the findings suggest its potential efficacy in treating symptoms of fibromyalgia-type Long COVID.

The second study, “Optimizing Acute Stress Reaction (ASR) Interventions with TNX-102 SL* – The OASIS Trial: Sustaining Civilian Performance Post-Trauma by Reduction of ASR and Prevention of ASD/PTSD,” aims to evaluate TNX-102 SL's efficacy in reducing the severity of acute stress reactions and preventing the onset of ASD and PTSD in civilians following traumatic incidents such as car accidents. The study is set to begin enrolling participants in the second quarter of 2024.

Dr. Lederman pointed out that prior trials of TNX-102 SL in treating PTSD have shown promising results in improving sleep and alleviating stress-related symptoms within the first few weeks of treatment. The OASIS trial is motivated by the hypothesis that enhancing sleep quality can reduce acute stress response symptoms, potentially offering a new treatment option that aids recovery and improves quality of life when administered soon after trauma.

Tonix Pharmaceuticals is preparing for the submission of an NDA to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for the management of fibromyalgia. Alongside TNX-102 SL, the company has a diverse portfolio that includes treatments for cocaine intoxication, organ transplant rejection, autoimmune diseases, and acute migraine.

As an integrated biopharmaceutical entity, Tonix is committed to developing therapeutics aimed at treating and preventing human diseases to alleviate suffering. The company’s extensive pipeline and ongoing research underscore its dedication to addressing critical and unmet medical needs across various therapeutic areas.