About two weeks ago, Dr. Valorie Masuda MD received approval from the Special Access Program (SAP) to treat six patients suffering from end-of-life distress with psilocybin and psychotherapy. In support of the SAP application, Psygen Lab Inc. donated the GMP synthetic psilocybin and Apex Labs provided access to its psilocybin investigators’ brochure.
This goes down as the first ever known case where psilocybin is being used in Canada’s SAP program since the Food and Drug Regulations were amended back in January 5, 2022 to allow access of psilocybin and other restricted drugs via the SAP program.
The six patients underwent the treatment at the beginning of the month by Roots to Thrive which was co-led by Dr. Masuda. TheraPsil, where Dr. Masuda is an associate physician and a board member referred some of the six patients were to doctor.
“This is a momentous occasion, the first legal access to a supply of GMP psilocybin in over 50 years. This is a major win for patients and doctors who have been left in the dark for the past 2 years with legal exemptions but no supply of psilocybin. Now that has changed and allowed for safe, Canadain made psilocybin to reach those who need it. There are thousands of patients and doctors on our waiting list eager to receive the same safe access and we look forward to helping them,” said the CEO of TheraPsil, Spencer Hawkswell.
Dr. Masuda prepared and filed the patients’ requests to SAP after their section 56 exemptions for compassionate access to psilocybin were either denied, or went unanswered, by the Health Minister, Jean-Yves Duclos.
“We worked collaboratively with the SAP team at Health Canada as well as the team at Psygen to make this happen,” said Dr. Masuda.