RED LIGHT HOLLAND PSILOCYBIN TRUFFLES, SOLD IN THE NETHERLANDS, COMPLETE SECOND EVALUATION UNDER A HEALTH CANADA APPROVED CGMP LABORATORY
Red Light Holland Corp. has received the second report produced by Shaman Pharma Corp. and CCrest Laboratories Inc. under a Health Canada controlled drugs and substances licence. This report was focused on perfecting potency assays and identifying variables such as water content and size that might influence the amount and the characteristics determining active ingredients (psilocybin and psilocin) in the truffles as a step toward creating a standardized consistent dose from naturally occurring psychoactive truffles.
"We continue to move towards creating a standardized consistent dose from naturally occurring psilocybin truffles that can potentially benefit both the hopeful recreational and medicinal markets," said Todd Shapiro, chief executive officer and director of Red Light Holland. "We are learning through market research and anecdotal movements that many people prefer naturally occurring psilocybin over synthetics -- so it's exciting that Red Light Holland with the help of Shaman Pharma are once again working aggressively within all legal means, and adding to the scientific knowledge of these natural products. We hope the Canadian government will see the need to provide patients, who are approved to use natural psilocybin, with an ability to access our tested products of known dosage."
"The progress we have made in the year 2021 was simply groundbreaking, which positioned our companies to start this new year with incredible momentum. We look forward to continuing and expanding our collaboration with Red Light Holland," said Alex Grenier, chief executive officer of Shaman Pharma and president of CCrest Laboratories. "The timely news regarding the special access program is in line with our expectations and we are fully committed to exceeding the exemplary regulatory standards put forward by Health Canada, hoping it will inspire the health authorities of other countries to follow without hesitation."
Now that a precise and specific analysis method (SP1-173-L) has been determined next steps will be taken to test its robustness and accuracy. Other substances were also identified in the truffles and more bibliography will be needed to identify other alkaloid compounds that might be present in the truffles such as norbaeocystin, baeocystin and aeruginascin, which will help research the possibility of an "entourage effect" in naturally occurring truffles.
From the report, it can be inferred that the size is not affecting the concentrations of psilocybin and psilocin, but the water content is an essential factor. In the case of large-sized truffles (galindoi and tampanensis) removal of water content, without degrading psilocybin, is a challenging task which in turn affects the extract concentrations. It can be observed from these results that the laboratory was successfully able to bring the raw material to their anhydrous state while maintaining the same ratio of active ingredients.
Future analysis will also expand research using scientific methods applied in pharmaceutical drug development, for instance determining the exact influence of light on the degradation of psilocybin and psilocin by doing a forced degradation study, and performing stability studies under various conditions. These studies can illustrate the chemical stability of the molecule which further facilitates the development of stable experimental design and suitable storage conditions. This information will aid in the development of lab-scale production projects to provide practitioners with quality-controlled psilocybin for their patients.
On Jan. 5, 2022, the controlled substances directorate of Health Canada announced that amendments were published and came into force immediately to restore the possibility for practitioners who are allowed to prescribe drugs to request access to restricted drugs, including psilocybin, through Health Canada's Special Access Program (SAP). With the regulations now amended, practitioners which are allowed to prescribe drugs can, on behalf of patients with serious or life-threatening conditions, request access to restricted drugs through the SAP when other therapies have failed, are unsuitable or are not available in Canada, among other conditions.
While all SAP requests will continue to be assessed on a case-by-case basis, and there is no guarantee that access to restricted drugs will be granted through the SAP, this much anticipated step forward validates the importance of the work performed at CCrest Laboratories with psilocybin truffles from Red Light Holland. Canada is leading the way in providing practitioners with a path for patients to access psilocybin, and it is critical to make it readily available through a legal and quality-controlled supply chain, and that practitioners can rely on specific, precise and consistent dosage.
Red Light Holland continues to establish itself as a leader in the recreational sector and push for legal, responsible and safe access to natural psychedelic truffles/mushrooms, while Scarlette Lillie Science and Innovation pursues research and development, technology and applied science.