Providence St. Patrick Hospital, the University of Montana and Tonix Pharmaceuticals Form Partnership for Phase 3 HONOR Study to Investigate the Safety and Efficacy of Tonmya® (Cyclobenzaprine HCl Sublingual Tablets) in Military Veterans with Post-traumatic Stress Disorder
Missoula, MT, Dec. 18, 2017 – Providence St. Patrick Hospital, the University of Montana and Tonix Pharmaceuticals Holding Corp. (Tonix) today announced the opening of a clinical site in Missoula for the Phase 3 HONOR study evaluating Tonmya* for the treatment of post-traumatic stress disorder (PTSD) in military veterans. The Missoula site is part of a nationwide study that could accelerate the development of new, effective and safe treatments for PTSD.
U.S. Sen. Jon Tester helped bring the study to Missoula to give Montana veterans and reservists a chance to participate in the trial of this investigational new treatment and to create a PTSD clinical research center in Montana
“This trial offers hope in addressing an urgent health crisis facing Montana’s veterans,” said Tester, ranking member of the Senate Veterans’ Affairs Committee. “When America’s finest return from deployment, they often face unseen wounds of war. It’s my sincere hope that through this trial we can identify a safe and effective treatment for those who served this nation.”
(A video with remarks from Tester is online at: https://sentester.app.box.com/s/g73x0m71anwfgkodbvfl4mp0ff55euwf.)
The study, sponsored by Tonix, is being conducted by the primary investigator at Providence St. Patrick Hospital and a sub-investigator at UM. Eligible participants are those who have experienced one or more traumatic events during military service since 2001 and are experiencing ongoing disabling post-traumatic stress symptoms such as nightmares, flashbacks, agitation, irritability and disturbances in sleep. Interested participants will receive a screening visit at Providence Psychiatry, including a thorough psychiatric and medical examination.
Eligible participants will receive either Tonmya or placebo, to be taken at bedtime daily for 12 weeks and return to the clinic for a baseline visit and monthly evaluations of PTSD symptoms and physical health. Upon completion of the 12-week double-blind treatment, all participants who were generally compliant with the study protocol will be offered an additional 12 weeks of treatment with Tonmya.
The Missoula site is part of the nationwide study targeting a total enrollment of up to approximately 550 participants. The safety and effectiveness of Tonmya for the treatment of PTSD will be compared with participants receiving placebo by the end of the 12 weeks.
“Providence St. Patrick Hospital has a long history of supporting research and innovation,” said Joyce Dombrouski, chief executive of Providence Montana. “The Phase 3 HONOR Study may lead to advancement of an effective treatment option for our veterans suffering from PTSD.”
“We are very excited to participate in this clinical research study to address public health challenges and unmet medical need,” said Reed Humphrey, dean of the UM College of Health Professions and Biomedical Sciences. “The Neural Injury Center at UM is fundamentally important to both the college and the university as we work to improve the quality of life among those with head injury and those suffering from PTSD and the quality of life for their families. Our efforts are directed to the research, education and clinical service for those with head injury and those suffering from PTSD. We hope our work in providing medical service and research will contribute to best medical practices for veterans and others who have suffered head injury and those suffering from PTSD. While the HONOR Study does not require a history of head injury to be eligible to participate, the study does include participants who suffered head injury that resulted in mild traumatic brain injury.”
“We are very excited to be a part of the HONOR study,” said Cindi Laukes, the center’s chief operating officer and a sub-investigator on the trial. “The Neural Injury Center is honored to assist injured veterans seeking PTSD screening or diagnosis, and our participation in this study will put us in the driver’s seat to search for effective new treatments.”
To participate in the trial, Montana veterans can visit www.thehonorstudy.com to see if they qualify and to enroll. If veterans qualify and choose to participate, they will receive study-related care at no cost. Veterans also will receive compensation for time and travel to attend study visits. Health insurance is not required to participate in the study, and a Certificate of Confidentiality is provided to participants to protect their privacy.
Participants do not need a previous diagnosis of PTSD to join the study. Montana veterans can contact Providence St. Patrick Hospital at 406-243-4017 for more information or to inquire about the study.
The Phase 3 HONOR study is an important part of a clinical development program to confirm the potential clinical benefit of Tonmya for PTSD. Because of the need to improve the current market of products for PTSD, especially military-related PTSD, Tonmya has been granted Breakthrough Therapy designation by the FDA.
“The preliminary evidence of improved clinical benefit of Tonmya for the treatment of PTSD has been recognized by the FDA,” said Seth Lederman, M.D., president and chief executive officer of Tonix. “We have FDA’s commitment to accelerate the development and review of this Breakthrough Therapy for PTSD. The support from Senator Tester helps to expedite the clinical development of Tonmya for an early New Drug Application (NDA) submission.”
*Tonmya has been conditionally accepted by the U.S. Food and Drug Administration (FDA) as the proposed trade name for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of PTSD. TNX-102 SL is an investigational new drug and has not been approved for any indication.