Tonix Pharmaceuticals has announced the dosing of the first patient in its Phase 2 OASIS (Optimizing Acute Stress Reaction Interventions with TNX-102 SL) trial. The investigator-initiated study will evaluate the potential of TNX-102 SL to reduce the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) in trauma survivors.
The trial is sponsored by the University of North Carolina (UNC) Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense (DoD). Topline results are expected in the second half of 2026.
Trial Design and Objectives
The OASIS trial will examine the safety and efficacy of TNX-102 SL in reducing adverse posttraumatic neuropsychiatric sequelae among patients presenting to emergency departments (ED) after motor vehicle collisions (MVC). The study plans to enroll approximately 180 MVC-trauma survivors at ED study sites across the United States.
Participants will be randomized in the emergency department to receive a two-week course of either TNX-102 SL 5.6 mg or placebo. The trial builds upon knowledge and infrastructure developed through the UNC-led $40 million AURORA initiative, a major national research program focused on improving understanding, prevention, and recovery for individuals who experience traumatic events.
"TNX-102 SL has been shown to improve sleep quality in PTSD, and previous trials suggested activity on sleep and stress-related symptoms in the first several weeks of treatment," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "Addressing sleep disturbances is crucial in managing ASR, as poor sleep can exacerbate other symptoms and hinder recovery."
Addressing a Significant Unmet Need
Acute and chronic stress disorders affect both civilian and military populations. According to the National Center for PTSD, approximately 60% of men and 50% of women in the U.S. experience at least one trauma in their lives. In the U.S. alone, one-third of ED visits (40-50 million patients per year) involve evaluation after trauma exposures.
Military personnel face particularly high rates of trauma exposure. A 2014 study involving 3,157 U.S. veterans found that 87% reported exposure to at least one potentially traumatic event during their service. As many as 500,000 U.S. troops who served in wars between 2001 and 2015 were diagnosed with PTSD.
Currently, no medication is available in the immediate aftermath of traumatic events to treat the initial reaction and support long-term health by preventing development or worsening of ASD, which could also prevent progression to PTSD.
About TNX-102 SL
TNX-102 SL is a centrally acting, non-opioid investigational drug designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for bedtime dosing, initially for the management of fibromyalgia.
Cyclobenzaprine acts as an antagonist at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. These interactions are believed to target non-restorative sleep, a characteristic of fibromyalgia identified by Professor Harvey Moldofsky in 1975. Importantly, cyclobenzaprine is not associated with risk of addiction or dependence.
The TNX-102 SL tablet utilizes a eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine efficiently into the bloodstream via the transmucosal route. This formulation was specifically designed for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep while reducing the risk of daytime somnolence.
Broader Development Program
TNX-102 SL is also being developed for the management of fibromyalgia. Tonix has submitted a New Drug Application (NDA) based on two statistically significant Phase 3 studies, with a PDUFA goal date of August 15, 2025, for a decision on marketing authorization. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia.
The OASIS trial represents an important expansion of TNX-102 SL's potential applications into acute stress conditions, potentially offering a new therapeutic option for patients experiencing trauma. The study is registered on ClinicalTrials.gov with the identifier NCT06636786.
About Tonix Pharmaceuticals
Tonix Pharmaceuticals Holding Corp. is a fully integrated biotechnology company with marketed products and a pipeline of development candidates. The company focuses on transforming therapies for pain management and vaccines for public health challenges.
Beyond TNX-102 SL, Tonix's development portfolio includes TNX-1500, an Fc-modified humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft rejection and treatment of autoimmune diseases. The company's infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, and TNX-4200, a small molecule broad-spectrum antiviral agent.
Tonix Medicines, the company's commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
