Creso Pharma Ltd (ASX:CPH, OTCQB:COPHF)’s wholly-owned, Canadian-based psychedelics subsidiary Halucenex Life Sciences Inc. has been included on a list of companies that can provide psychedelic compounds to researchers and patients under the SAP.
More broadly, this means Halucenex may provide patients with previously restricted psychedelic substances, under certain circumstances, following Health Canada guidelines.
The SAP is a federal program that allows healthcare professionals to apply for access to non-marketed medications that have not yet been approved for sale.
This can only occur if the medications show clinical evidence of safety and efficacy and are intended to treat patients with severe or life-threatening illness.
Included in the list of medications is psilocybin and Halucenex is one of only several suppliers that doctors and patients who obtain permission will be directed to for the supply of psychedelic substances.
Psilocybin may be used for treating Post-Traumatic Stress Disorder (PTSD) and is part of a therapeutics sector expected to grow to US$10.5 billion in value by 2025 providing Creso Pharma with a major market opportunity.
Psilocybin access
The changes to the SAP were announced on January 5 2022 in the Government of Canada’s official newspaper, the Canada Gazette.
This announcement reversed a 2013 decision that prohibited a range of restricted drugs, including psilocybin, in the treatments for mental health and other health conditions.
The new regulations allow medical practitioners, on behalf of patients with serious to life-threatening conditions, to be able to request restricted drugs through the SAP.
Halucenex is now on a list of suppliers who can give doctors access to psilocybin for their patients.
Treatment options growing
“We commend Health Canada’s continued progress towards providing treatment options to those needing support to combat serious or life-threatening conditions,” Halucenex president, CEO and founder Bill Fleming said.
“Becoming an approved supplier of psychedelic compounds for the Special Access Program provides Halucenex with a new potential revenue stream and cements our place as one of Canada’s leading drug development and supply company.
“It’s encouraging to see policy makers begin to recognise the potential for psychedelic medicines for both its medicinal and research capabilities.
"As the public demand for psychedelic medicines increases, we hope to continue to witness a change in the regulatory landscapes to allow us to fully utilise the application of these innovative medicines.
"We are now focused on working with our network of partners to begin the supply of our Good Manufacturing Practice (GMP) quality grade synthetic psilocybin to doctors and patients under the SAP.”