The FDA issued a letter saying that we had successfully resolved all the outstanding issues in our Investigative New Drug application (#101,825) to evaluate LSD-assisted psychotherapy in our Swiss end-of-life/anxiety pilot study (PDF). FDA is now open to the possibility of the therapeutic potential of LSD-assisted psychotherapy and will accept data from our Swiss study.
FDAs acceptance of our pilot study for our Swiss LSD/end-of-life anxiety protocol is the culmination of the first phase of the psychedelic renaissance, MAPS President Rick Doblin PhD remarked emphatically.
It has taken several years for MAPS to reach this milestone with the FDA, This approval bolsters the belief that patience is the fastest way towards legitimizing psychedelic psychotherapy. In our culture, LSD is the most controversial of all the psychedelic drugs due to its association with the cultural rebellion of the 1960s, the implications of which are both celebrated and feared. The FDA has previously approved research with MDMA, psilocybin, DMT, ketamine, and mescaline. LSD is the last of the classic psychedelic drugs to be accepted as a research tool again, and the acceptance by the FDA of our Swiss LSD protocol is a transformative moment in the ongoing psychedelic renaissance.
The budget for our Swiss LSD/end-of-life anxiety study is $225,000. Weve raised about $125,000 and are still seeking the final $100,000.