A Department of Defense arm responsible for advancing medicine for U.S. Forces signed an agreement today with Tonix Pharmaceuticals (NASDAQ: TNXP) to explore expansion and potential development of a new drug for the treatment of military-related post-traumatic stress disorder (PTSD).
The new drug, TNX-102 SL (cyclobenzaprine HCl sublingual tablets), is a rapidly dissolving tablet containing very low dose cyclobenzaprine that is administered under the tongue (sublingual) for quick absorption into the blood stream. It is designed for use at bedtime to improve sleep quality and to be tolerable for long-term treatment.
The active ingredient of TNX-102 SL, cyclobenzaprine, is one of most widely prescribed medications in the U.S. as an acute treatment for muscle spasm. As a sublingual, low-dose formulation for use at bedtime, TNX-102 SL is designed to improve sleep quality.
TNX-102 SL is currently in Phase 3 clinical studies for use by sufferers of fibromyalgia, who experience both pain and poor sleep. See this National Pain Report article for more information on the study.
The U.S. Army Medical Materiel Development Activity (USAMMDA) is the Department of Defense’s (DoD) initiative to develop new drugs, vaccines and medical support equipment that enhance readiness, and ensures the provision of the highest quality medical care to the DoD.
USAMMDA project managers guide the development of medical products, taking promising technology from DoD and academia to U.S. Forces. They oversee the testing required for FDA approval or licensing to fielding of the finished product. With the signing of a Cooperative Research and Development Agreement (CRADA) with Tonix, the USAMMDA will begin its process of developing and assessing TNX-102 SL for sleep disorders associated with military-related PTSD.
The National Institute of Mental Health describes PTSD this way:
“When in danger, it’s natural to feel afraid. This fear triggers many split-second changes in the body to prepare to defend against the danger or to avoid it. This “fight-or-flight” response is a healthy reaction meant to protect a person from harm. But in post-traumatic stress disorder (PTSD), this reaction is changed or damaged. People who have PTSD may feel stressed or frightened even when they’re no longer in danger.
PTSD develops after a terrifying ordeal that involved physical harm or the threat of physical harm. The person who develops PTSD may have been the one who was harmed, the harm may have happened to a loved one, or the person may have witnessed a harmful event that happened to loved ones or strangers.
PTSD was first brought to public attention in relation to war veterans, but it can result from a variety of traumatic incidents, such as mugging, rape, torture, being kidnapped or held captive, child abuse, car accidents, train wrecks, plane crashes, bombings, or natural disasters such as floods or earthquakes.”