Skip to main content

Led by Sam McLean, MD, MPH, University of North Carolina School of Medicine researchers and collaborators were awarded $3 million from the U.S. Department of Defense to evaluate the efficacy of a therapeutic by Tonix Pharmaceuticals to reduce the frequency and severity of acute stress disorder and posttraumatic stress disorder.

CHAPEL HILL, NC – The UNC Institute for Trauma Recovery in the UNC Department of Psychiatry has been awarded a $3-million grant from the U.S. Department of Defense (DoD) to investigate the potential of a therapeutic agent to reduce the frequency and severity of acute stress reaction (ASR), acute stress disorder (ASD) and post-traumatic stress disorder (PTSD). Acute stress disorder refers to the body’s immediate response to trauma, whereas PTSD is the long-term effects of trauma.

“In addition to emergency care to treat and help patients recover from physical wounds, whether in the emergency room or the battlefield, we must also address the unmet need for treatment options to address ‘invisible wounds’ that survivors may experience following a traumatic event,” said Samuel McLean, MD, professor of psychiatry and emergency medicine at the UNC School of Medicine and lead principal investigator of the proposed study. “To address these needs, we are investigating a potential therapy for patients who experience trauma and traumatic stress.”

The proposed OASIS trial will examine the safety and efficacy of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) – an investigational new drug and is not approved for any indication – to reduce acute stress response symptoms, posttraumatic stress disorder symptoms and behavioral changes among patients presenting to the emergency department after a motor vehicle collision.

The OASIS trial builds upon a foundation of knowledge and infrastructure developed through the UNC-led, $40 million AURORA initiative. The AURORA study is a major national research initiative to improve the understanding, prevention, and recovery of individuals who have experienced a traumatic event. AURORA is supported by funding from NIH, One Mind, private foundations, and partnerships with leading tech companies such as Mindstrong Health and Verily Life Sciences, the healthcare arm of Google’s parent company Alphabet.

“No medications are currently available at or near the point of care to treat patients suffering from traumatic events and support long-term health, whether U.S. military exposed to life-threatening events or civilians experiencing traumatic events such as motor vehicle collisions,” said Gregory Sullivan, MD, Chief Medical Officer of Tonix. “Acute stress reaction and posttraumatic stress symptoms are common among civilian motor vehicle collision survivors. The AURORA study, which has collected thousands of data points from motor vehicle collisions, will allow us to better investigate the correlation between motor vehicle collisions and the emergence of acute stress disorder or PTSD symptoms. And leveraging support from the AURORA study and utilizing the DoD’s non-dilutive capital to primarily fund TASER allows Tonix and UNC to streamline trial efficiency, reduce costs, and increase trial power through enriching the target patient population.”

Added Brandon Staglin, President of One Mind, “For individuals who experience trauma and traumatic stress, the need for effective treatments is an urgent one. The OASIS trial’s focus on evaluating a promising potential treatment option exemplifies the kind of evidence-based outcomes One Mind and our partners hoped to achieve as part of the AURORA initiative’s broader efforts to improve the lives of trauma survivors.”

Acute and chronic stress disorders can affect both civilian and military populations. According to the National Center for PTSD, in the U.S. about 60% of men and 50% of women experience at least one trauma in their lives. In the United States alone, one-third of emergency department visits (40-50 million patients per year) are for evaluation after trauma exposures, and in a 2014 study involving 3,157 US veterans, 87% reported exposure to at least one potentially traumatic event during their service. Moreover, as many as 500,000 U.S. troops who served in wars between 2001 and 2015 were diagnosed with PTSD.

UNC School of Medicine Media Contact: Mark Derewicz, 919-923-0959