FDA Approves Clinical Application For US Trials Of Pot For Head Trauma

Thursday, 20 February 2003

Iselin, NJ: An Israeli-based pharmaceutical company announced this week that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to begin Phase III human trials in the United States on the effectiveness of the synthetic marijuana derivative Dexanabinol for the treatment of Traumatic Brain Injury (TBI). It is the first time that US regulatory officials have sanctioned such trials to take place in America.

Phase III is the final stage of drug testing before regulatory approval.

Hundreds of Americans are anticipated to take part in the trials, joining more than 500 patients already enrolled in over 60 neurotrauma centers throughout Europe, Australia and Israel. "Subject to the results of the study, we intend to submit the data of the combined international and US study to the FDA and to other international regulatory agencies for worldwide marketing approvals," said Pharmos Company President Gad Riesenfield. "If approved, Dexanabinol would be the first pharmaceutical product for head injury."

A previous Phase II trial by Pharmos of 67 Israeli patients demonstrated that Dexanabinol reduced mortality and eased intracranial pressure in volunteers suffering from severe head injuries. A 1998 U.S. Army rat study also reported that the administration of Dexanabinol five minutes after the onset of nerve gas-induced seizures significantly reduced brain damage.

Similar research conducted by scientists at the National Institutes for Mental Health found that naturally occurring cannabinoids THC and cannabidiol (CBD) are also neuroprotective. A 1999 report by the National Academy of Sciences' Institute of Medicine (IOM) called cannabis' neuroprotective qualities the "most prominent" of its potential therapeutic applications.

For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at (202) 483-5500.