It’s my pleasure to report some excellent news. About 10 AM, Friday, November 2, FDA contacted me to say that MAPS’ MDMA/PTSD protocol was approved. This approval marks the culmination of 16 years of efforts to obtain permission from FDA for MDMA-assisted psychotherapy research, since MDMA was criminalized in 1985. This approval also marks the beginning of what I hope will be a $5 million, 5-year project to develop MDMA into a prescription medicine.
On Wednesday, Dr. Michael Mithoefer, the principal investigator, and I had a conference call with FDA during which we discussed various design issues. The conference call was calm, serious and respectful. We agreed to make several design changes, mainly closer monitoring of blood pressure and omitting the opportunity for placebo subjects who still met inclusion criteria for PTSD at the final evaluation to enroll in an open label extension study during which they would receive MDMA. We argued against several other possible changes, mainly the idea that patients should be required to have had prior experience with MDMA. On Thursday, I faxed an addendum specifying the changes we had agreed upon and the places where the protocol needed to be changed. Last night, I saw on CNN that anthrax was discovered in the FDA mailroom at Rockville, where the FDA officials reviewing the protocol work. Today, FDA officials were still at work and informed me that the protocol was approved without the need for any additional changes.
Of course, we still need to obtain Institutional Review Board approval from the Medical University of South Carolina. This should take several additional months.
I’ve already let the Israeli Ministry of Health know that the FDA approved the study. According to Dr. Moshe Kotler, the principal investigator of the proposed Israeli MDMA/PTSD protocol, FDA approval was need for an MDMA/PTSD study before he would feel comfortable submitting a protocol to the Ministry. The subjects in the ongoing Spain MDMA/PTSD study are women survivors of sexual assault with chronic PTSD. The subjects in the FDA-approved study are women and men survivors of criminal assault with chronic PTSD. The Israeli study will hopefully include subjects whose PTSD was the result of war and terrorism.
The formal approval letter from FDA will arrive next week. — Rick Doblin, Ph.D.
