A phase 3 study found that bedtime sublingual cyclobenzaprine (TNX-102 SL), an investigational drug being developed by Tonix Pharmaceuticals Holding Corp, is well-tolerated and showed nominal improvement in post-traumatic stress disorder (PTSD) severity and sleep quality measures in the first four weeks in military-related PTSD.

Tonix believes these findings, published in Psychiatry Research, suggest a potential role for short-term bedtime TNX-102 SL treatment in the immediate aftermath of traumatic events.

The data support the US Department of Defense-funded phase 2 investigator-initiated OASIS trial to evaluate bedtime TNX-102 SL2 in reducing the severity of acute stress reaction and the frequency of acute stress disorder and PTSD. The Investigational New Drug application supporting the OASIS trial was recently cleared, and the trial is expected to begin enrolling in the second quarter. 

The trial is sponsored by The University of North Carolina Institute for Trauma Recovery and supported by a $3 million grant from the Department of Defense. In the OASIS study, 14 days of bedtime TNX-102 SL 5.6 mg will be tested in the immediate aftermath of motor vehicle collision. 

The study will test the potential for TNX-102 SL treatment initiated within 24 hours of index trauma to target trauma-related sleep disturbance and other acute stress reaction symptoms to facilitate recovery from acute stress reaction and to prevent PTSD.

“There is an urgent need for interventions to reduce rates of [acute stress disorder] and PTSD in the immediate aftermath of trauma,” says Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals, in a release. “We believe the results in the published paper suggest that bedtime TNX-102 SL has short-term activity on improving PTSD symptom severity and sleep quality in military-related PTSD. Poor sleep after trauma is a risk factor for progressing from [acute stress disorder] to PTSD. Therefore, poor sleep is not only a symptom of [acute stress reaction], [acute stress disorder], and PTSD but also a potential target of therapy.”

Gregory Sullivan, MD, chief medical officer of Tonix, says in a release, “Sleep disturbances are known to play a critical role in the development and maintenance of PTSD. The upcoming OASIS trial will test a 14-day short-course of bedtime TNX-102 SL therapy beginning within 24 hours of index trauma for effects on ASR symptoms and incidence of PTSD development. We are excited to test bedtime TNX-102 SL in the immediate aftermath of trauma to learn whether drug intervention reorients the trajectory of posttraumatic pathology from acute trauma to early recovery in the first few weeks.”

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