Tonix Begins Phase 2 Study of TNX-102 SL for Acute Stress Reaction, Targeting PTSD Prevention

Tonix Pharmaceuticals (TNXP) has begun dosing patients in a new Phase 2 trial evaluating TNX-102 SL for the treatment of acute stress reaction (ASR), a condition often triggered by traumatic events such as car accidents or military experiences. The study, known as OASIS, is being led by the University of North Carolina and is backed by a $3 million grant from the U.S. Department of Defense.

TNX-102 SL is a sublingual tablet formulation of cyclobenzaprine, a compound originally developed as a muscle relaxant. It's being repurposed by Tonix for central nervous system disorders, with prior trials showing potential benefits in improving sleep quality and reducing symptoms in patients with post-traumatic stress disorder. This new trial aims to assess whether early intervention with TNX-102 SL after trauma can reduce the severity of ASR and prevent the progression to more chronic conditions like PTSD.

The OASIS study will enroll approximately 180 trauma survivors who visit emergency departments following motor vehicle collisions. Participants will be randomly assigned to receive either TNX-102 SL at a 5.6 mg dose or a placebo for two weeks. The trial builds on the groundwork laid by the AURORA initiative, a $40 million national research effort funded by the NIH and other partners, including Alphabet's Verily.

Tonix expects topline results from the study in the second half of 2026.

The company highlights a growing need for therapies that address mental health challenges immediately following trauma. Acute stress disorders impact both civilian and military populations, with roughly one-third of emergency department visits in the U.S. linked to trauma exposure. Currently, no FDA-approved medications exist for the prevention or early treatment of ASR, creating an unmet medical need.

TNX-102 SL is already being reviewed by the FDA for fibromyalgia, with a regulatory decision expected in August 2025. It is designed to be taken at bedtime and rapidly absorbed through the mucosal lining, offering a fast-acting, non-addictive approach to managing sleep and stress-related symptoms.

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COMTEX_465679795/2927/2025-05-21T11:31:29