Canadian Study: Health Canada Approves Security Measures after Fifth Pharmacy Inspection

On November 8, 2012, after five inspections and over 15 months of resulting delays, an inspector from Health Canada finally approved the security measures at the Vancouver pharmacy where the MDMA will be stored for our upcoming Canadian study of MDMA-assisted psychotherapy for PTSD. New security regulations created after the initial inspection required us to make numerous expensive changes to the pharmacy, including hiding the safe with a wooden cabinet, moving the safe and cabinet to a new room with a solid (rather than glass) door, installing multiple new alarm systems, adding bulletproof polycarbonate over the windows, and placing additional warning labels on the study drug.

We have been working for 2½ years (since Health Canada approved the protocol) to obtain an import permit for the study drug. We’ve been told that once Health Canada grants the Controlled Substances License to the study pharmacist in January 2013 it will also issue an import permit to bring MDMA from Switzerland into Canada and initiate the study. We are cautiously hopeful that we will be able to initiate the study in February 2013 and begin enrolling subjects in March. We’ve been wrong before, but we’re definitely making progress.