Numinus Wellness and the Multidisciplinary Association for Psychedelic Studies Public Benefit Corp. (MAPS PBC), a MAPS subsidiary, have announced they are seeking approval for the use of MDMA-assisted psychotherapy for post-traumatic stress disorder through a compassionate access trial in Canada.
Compassionate access trials are recommended by Health Canada for patients not eligible for enrollment in other trials in cases where drug manufacturers anticipate high demand for a drug. Numinus recently announced plans for a separate compassionate access trial for psilocybin-assisted psychotherapy to treat substance use disorders.
If this latest pitch is approved, the trial will be conducted in Numinus’ clinic in Vancouver. The plan calls for 20 individuals experiencing PTSD to be provided with MDMA-assisted psychotherapy. Numinus physicians, therapists and staff will be trained on delivery of the treatment under MAPS’s PTSD protocol prior to approval by Health Canada.
“Training Numinus therapists in the MDMA-assisted psychotherapy protocol for PTSD will provide a meaningful expansion of access to the ongoing research program for this promising treatment,” MAPS PBC CEO Amy Emerson said in a news release. “Though this treatment is still investigational, if approval is granted through the regulatory pathway, this collaboration will bolster our shared goal of addressing the enormous—and growing—need for improved proven treatments for people suffering from PTSD.