Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to share significant news regarding the company's latest development: the clearance of the Investigational New Drug application by the U.S. Food and Drug Administration for the Phase 2 investigator-initiated OASIS trial.
This trial aims to evaluate the efficacy of TNX-102 SL in reducing the severity of acute stress reaction and the frequency of acute stress disorder and post traumatic stress disorder. Dr. Lederman explained that the trial is sponsored by The University of North Carolina Institute for Trauma Recovery and is supported by a substantial 3 million dollar grant from the U.S. Department of Defense.
The primary objective of the trial is to assess the safety and efficacy of TNX-102 SL in mitigating adverse posttraumatic neuropsychiatric effects among patients who present to the emergency department following a motor vehicle collision.
The trial is expected to enroll approximately 180 trauma survivors across various emergency department study sites throughout the United States. Participants will be randomly assigned to receive either TNX-102 SL 5.6 mg or a placebo for a two-week course.
Notably, there is currently a lack of medication available at or near the point-of-care to effectively address the needs of patients suffering from traumatic events and support their long-term health.
This development underscores Tonix Pharmaceuticals' commitment to addressing unmet medical needs in the field of trauma recovery and psychiatric disorders. With the initiation of the OASIS trial, the company aims to contribute to the advancement of treatment options for individuals experiencing acute stress reactions and related neuropsychiatric sequelae following traumatic events.
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