Iselin, NJ: The Pharmos pharmaceutical company announced on Tuesday the commencement of the first ever Phase III US study on the effectiveness of the synthetic marijuana derivative Dexanabinol for the treatment of Traumatic Brain Injury (TBI).
An estimated 270 US patients in some 15 trauma centers will take part in the double blind, randomized, placebo controlled trail. US patient recruitment is expected to be completed by the end of the year.
Worldwide, Pharmos has already enrolled some 630 patients throughout Europe, Australia and Israel to participate in the trial. Results from the trial are expected to be available late next year. "Positive data from the [Phase III] study could enable Pharmos to submit an NDA (New Drug Application) to the FDA (Food and Drug Administration) requesting marketing approval in the US as the first therapeutic treatment for TBI," the company said in a press release."
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 National Academy of Sciences' Institute of Medicine (IOM) concluded that marijuana's neuroprotective qualities are the "most promient" of its potential therapeutic applications.