Overdose Research Grant Awarded To Chatham-Based Pharma Company

CHATHAM, NJ — A Chatham-based pharmaceutical company that specializes in repurposed drugs for central nervous system conditions has received a federal grant to expand its research into TNX-1300 as a potentially life-saving treatment for cocaine overdoses.

Tonix is a clinical-stage biopharmaceutical company based in Chatham that focuses on discovering, licensing, acquiring, and developing therapeutics to treat and prevent human disease and alleviate suffering.

Representative Mikie Sherrill announced on Monday, July 25, that the U.S. Department of Health and Human Services will award Tonix Pharmaceuticals a federal National Institute on Drug Abuse (NIDA) grant to expand their research into TNX-1300.

Tonix's corporate headquarters are in Chatham, and their research and development facility is in Frederick, Maryland.

“This grant award underscores the unmet need for safe and effective treatments for cocaine intoxication and validates the progress we achieved to date with TNX-1300,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Cocaine overdose remains a serious issue in the U.S. where there is currently no specific pharmacotherapy indicated treatments. By targeting the cause rather than the symptoms of cocaine intoxication, we believe TNX-1300 may offer significant advantages to the current standard of care for a cocaine overdose.”

During their first terms in office, Sherrill and Maryland Representative David Trone formed the Freshmen Working Group on Addiction, a bipartisan effort to promote policies to end the addiction crisis.

“The research Tonix is pursuing is a bright light in our shared goal of reducing overdose deaths and harm as we continue to battle the crisis in substance use disorders in New Jersey and across the country, which has only been compounded by the pandemic. This targeted treatment could bring down healthcare costs and, most importantly, loss of life due to cocaine overdose,” Sherrill said.

Both Sherrill and Trone were instrumental in obtaining critical funding for State Opioid Response Grants and Tribal Opioid Response Grants, which will help states reduce overdose deaths through prevention, treatment, and recovery efforts, officials said.

“With this federal grant, Tonix will be able to move one step closer to FDA authorization and getting this potentially life-saving treatment into the hands of emergency room doctors and nurses, as well as EMS and other first responders,” Sherrill said.

According to Tonix, they have currently started work on the design of a new phase 2 clinical trial of TNX-1300. “The design of the new Phase 2 trial has the potential to serve as a pivotal trial,” Lederman said. “There are approximately 505,000 emergency room visits annually involving cocaine use, with approximately 61,000 of the visits involving detox services to treat cocaine overdose. In 2020, about 19,447 overdose deaths involving cocaine occurred in the U.S.2 We believe that TNX-1300 has the potential to be a new treatment option for the substantial morbidity and mortality caused by cocaine intoxication.”

There is no specific pharmacotherapy for cocaine intoxication, which causes acute agitation, hyperthermia, tachycardia, arrhythmias, and hypertension, as well as potentially fatal respiratory failure and seizures. Patients are currently receiving only supportive care for the negative effects of a cocaine overdose on the cardiovascular and nervous systems.

Tonix believes that by addressing the underlying cause of cocaine intoxication rather than the symptoms, TNX-1300 may offer significant benefits over the current standard of care for a cocaine overdose.