TheraPsil, a Canadian coalition for psilocybin therapy legalization, together with the U.K. independent foundation Drug Science, has launched Project Solace.
The goal is to gather data to better inform patients about the development of regulated psilocybin products. That way it can document clinical effectiveness, safety, clinician and patient-reported outcomes in those receiving medical psilocybin-assisted psychotherapy via the Canadian Special Access Programme (SAP) or under exemptions that authorize psilocybin possession.
Project Solace also hopes to expand legal access to medical psilocybin for Canadian patients suffering from end-of-life distress, Major Depressive Disorder (MDD) or other mental health conditions for which traditional treatment options have failed.
Regarding the potential patient benefit the SAP holds, Drug Science founder David Nutt expressed that it could be “a life-changing opportunity to receive psilocybin-assisted psychotherapy from a team of trained medical professionals.”
The clinical trial procedure is not an appropriate process for many patients due to the severity of the conditions that psilocybin-assisted psychotherapy attends to treat, Nutt added.
And that’s where the new venture comes in. “Project Solace will be the largest database of prescribed psilocybin in the world and real-world data gathering helps us to understand how these drugs are affecting patients," he added.
TheraPsil director of research Julia Joyes expalined that SAP represents "a giant leap forward" when it comes to healthcare and allows unprecedented early access to medications that are on the path to full Health Canada approval.
"This expanded access also presents an invaluable opportunity to collect real-world data on the use of psychedelic medicine in clinical practice. We should certainly cherish this opportunity,” she said.
How Prescriptions Will Work
One important distinction to be made is that the project does not constitute a clinical trial. Rather, it is intended to provide patients a medical psilocybin prescription.
Through Project Solace, TheraPsil will support prescribing healthcare practitioners in Canada to request psilocybin-based medical products on behalf of their patients through the SAP.
Also, on behalf of ensuring patient safety and treatment efficacy, TheraPsil aims to identify and connect prescribing healthcare professionals with trained treatment therapy teams across Canada for psilocybin-assisted psychotherapy.
Project Solace is set to begin assisting patients in British Columbia, Ontario and Quebec, and has plans to expand as additional treatment teams are onboarded.
Amongst others, biotech psychedelic companies HAVN Life Sciences Inc. HAVLF and Filament Health Corp. FLHLF will be participating on the project.
On behalf of TheraPsil, the organization has previously facilitated prescriptions for medical psilocybin products in accurate months, which they expect to continue doing in an exponential way backed by three psilocybin manufacturers.
The anonymized data collected through the project will be provided to regulatory bodies including Health Canada, to facilitate decision-making surrounding the regulatory system for the future of medicalized psilocybin. The data will also be released to licensed dealers enrolled in Project Solace and to the general public.
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