FDA Approves DoD-Funded Trial for TNX-102 SL to Treat Acute Stress and Prevent PTSD

Tonix Pharmaceuticals, a biopharmaceutical firm, has received FDA clearance for the Phase 2 OASIS trial, which will assess the impact of TNX-102 SL on acute stress reaction (ASR) and the development of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) in trauma patients. The study, led by the University of North Carolina (UNC) Institute for Trauma Recovery and funded by a $3 million grant from the U.S. Department of Defense (DoD), will involve 180 patients who have experienced motor vehicle accidents.

The OASIS trial aims to determine the safety and efficacy of TNX-102 SL in reducing the negative neuropsychiatric effects following trauma, with a focus on patients visiting emergency departments after motor vehicle collisions. The trial will be conducted at various emergency department sites across the U.S., with participants receiving either TNX-102 SL 5.6 mg or a placebo for two weeks.

Building on the knowledge and infrastructure from the UNC-led AURORA initiative, which is a $40 million national research program aimed at improving the understanding and recovery of trauma victims, the OASIS trial will test a pharmacological intervention immediately after trauma. The goal is to provide rapid relief of stress symptoms, improve coping and functioning, and prevent the escalation to more severe conditions.

Stress disorders are prevalent among both civilian and military populations. The National Center for PTSD reports that approximately 60% of men and 50% of women in the U.S. experience at least one trauma in their lives. Furthermore, one-third of emergency department visits in the U.S. involve trauma evaluations, and a significant number of veterans have reported exposure to potentially traumatic events.

Tonmya, also known as TNX-102 SL, is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride designed to improve sleep quality in fibromyalgia. It is a multifunctional agent with potent binding and antagonist activities at various receptors and is currently in development for several conditions, including fibromyalgia-type Long COVID, alcohol use disorder, and Alzheimer’s disease agitation. Tonix Pharmaceuticals holds several patents for Tonmya, which are expected to provide market exclusivity until 2034/2035.

Tonix Pharmaceuticals is dedicated to commercializing, developing, discovering, and licensing therapeutics for various human diseases, with a focus on central nervous system disorders. The company is preparing to submit a New Drug Application (NDA) for Tonmya, which has completed two positive Phase 3 studies for fibromyalgia management. Other development candidates include TNX-1300, a biologic for cocaine intoxication, and TNX-2900, for the treatment of Prader-Willi syndrome, among others.

Tonix Medicines, the company's commercial subsidiary, markets Zembrace® SymTouch® and Tosymra®, indicated for the treatment of acute migraine in adults. The company continues to innovate and develop new treatments to address a range of health conditions.