CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a biopharmaceutical company, announced results from a study indicating that its drug TNX-102 SL demonstrated nominal improvement in the severity of PTSD symptoms and sleep quality within the first four weeks of treatment. The findings, published in Psychiatry Research, suggest potential for the drug's short-term use following traumatic events.
The research focused on military-related PTSD, with the drug showing early signs of efficacy in improving Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores and sleep disturbance measures. Despite these initial improvements, the study did not achieve statistical significance at its primary endpoint at Week 12.
Additionally, the company highlighted the upcoming Department of Defense-funded Phase 2 OASIS trial, which will assess the impact of TNX-102 SL on acute stress reaction (ASR) and the prevention of acute stress disorder (ASD) and PTSD when administered within 24 hours of a traumatic event, such as a motor vehicle collision.
The OASIS study, expected to commence enrollment in the second quarter, will test a 14-day course of the drug. The trial aims to address the urgent need for interventions that can mitigate the progression from ASD to PTSD, particularly targeting trauma-related sleep disturbances.
TNX-102 SL, also known as Tonmya™ for the management of fibromyalgia, is in late-stage development, with plans to submit a New Drug Application to the U.S. Food and Drug Administration in the latter half of 2024. The drug utilizes a sublingual tablet formulation of cyclobenzaprine hydrochloride, designed for bedtime administration to potentially improve sleep quality in fibromyalgia patients.
Tonix Pharmaceuticals is also exploring TNX-102 SL's applications for fibromyalgia-type Long COVID, alcohol use disorder, and agitation in Alzheimer’s disease. The company holds several patents expected to provide U.S. market exclusivity until at least 2034, pending approval.
This information is based on a press release statement from Tonix Pharmaceuticals.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.