For those unaware, Canada provides a legal way for patients presenting unresolved mental health issues to receive psychedelic-assisted treatment. While the country still has not provided legal status to psychedelics, recent amendments have made it possible for health practitioners to request permission to access restricted drugs for patients with serious or life-threatening conditions for whom other therapies have proven unsuitable or failed.
The authorization, granted by Health Canada through its Special Access Program, is therefore strictly related to each patient’s situation, on a case-by-case basis, while also considering the level of scientific evidence, including that pertaining to safety and efficacy, to support the drug’s use for the treatment of each patient’s specific condition.
As reported by the Canadian government’s official newspaper, requests to the Special Access Program (SAP) are normally only considered when positive results of Phase 2 or Phase 3 (the highest stage a drug can achieve in clinical research before aiming for legal approval) clinical trials are already available.
The process goes as follows: When the SAP authorizes the sale of a specified quantity of an unapproved -and unmarketed- drug, the requesting practitioner must provide the name and the civic address of the facility to which the drug will be shipped. The person who receives the shipment of the drug must be a practitioner or a pharmacist.
It is also worth noting that practitioners who initiate requests on behalf of their patients are responsible for ensuring that they are informed of all possible risks and benefits of the drug being requested as well as its development status.
After the drug-assisted therapy, health practitioners must complete a reporting form including dose alteration (if applied), treatment response, general outcomes and adverse reactions.
The newest drug candidate to be granted permission for treatment is a proprietary compound of Filament Health Corp. FLHLF, a clinical-stage natural psychedelic drug development company. Market authorization of Filament's drug candidates has not yet been granted by Health Canada or any other health authority.
Recently, a press release by Braxia Scientific Corp. BRAXF reported positive results from its multi-dose psilocybin trial will most likely facilitate psilocybin prescription through the Health Canada Special Access Program by physicians on a case-by-case basis to patients in need.
Earlier this year, synthetic psilocybin (donated by the Canadian biotech company Apex Labs) was used in combination with psychotherapy for six patients experiencing end-of-life distress. This was the first known case of psilocybin being approved through Canada’s SAP since the January amendments to the Food and Drug Regulations.
Photo Courtesy of ELG21 on Pixabay.
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