FDA Grants "Fast Track" Status To Pot-Like Drug For Head Trauma

Thursday, 02 October 2003

Iselin, NJ: The US Food and Drug Administration (FDA) will review the efficacy of the synthetic marijuana derivative Dexanabinol for the treatment of Traumatic Brain Injury (TBI) on an accelerated basis, the Pharmos pharmaceutical company announced this week. The FDA grants so-called "fast track" status to drugs intended to treat life-threatening conditions for which no approved therapies exist.

Fast track status allows companies to submit their clinical data to the FDA in stages while trials remain ongoing. Dexanabinol is currently being tested in advanced Phase III clinical trials in the US and Europe. A previous Phase II trial by Pharmos of 67 Israeli patients found that Dexanabinol reduced mortality and eased intracranial pressure in patients suffering from severe head injuries.

A 1999 report by the US National Academy of Sciences' Institute of Medicine (IOM) concluded that marijuana's neuroprotective qualities are the "most prominent" of its potential therapeutic applications.

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