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Application Filed With FDA For U.S. Clinical Trials On Pot For Head Trauma

Thursday, 14 November 2002

Iselin, NJ:  An Israeli-based pharmaceutical company announced recently that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin Phase III human trials on the effectiveness of the synthetic marijuana derivative Dexanabinol for the treatment of Traumatic Brain Injury (TBI).  If their application is approved, it will be the first time that such human trails have been conducted in the U.S.

A previous Phase II trial of 67 Israeli patients by the Pharmos Corporation demonstrated that Dexanabinol reduced mortality and eased intracranial pressure in patients suffering from severe head injuries.

Currently, more than 400 patients worldwide are taking part in the Phase III study on Dexanabinol, including volunteers from Australia, France and Germany.  Pharmos hopes to establish an additional 30 recruitment centers in the U.S. to assist with the study, according to the company's press release.

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

For more information, please contact Paul Armentano, NORML Director of Publications and Research, at (202) 483-5500.