Numinus Wellness (TSX: NUMI) has stood out in the sector for its diligent support of amendments to Health Canada’s longstanding Special Access Program. After changes to the program were made last week, The Dales Report sat down with CEO Payton Nyquvest to discuss their significance.
The Special Access Program, or SAP, is a longstanding program run by Canada’s federal health agency that provides patients in need with emergency access to drugs or therapies that have represented significant benefit but may not be accessible to patients for a variety of reasons. This includes drugs that have yet to go through the full clinical trial process, as well as drugs that may not be available in Canada.
“Any data that shows a positive result through a phase two or phase three study (which, with psychedelics, there are quite a few) gives unlimited amounts of Canadians access to those drugs or therapies,” said Nyquvest. “So, it’s a huge advancement… I don’t think it can be understated.”
The CEO said one thing he was pleasantly surprised to see within the document that detailed the amendments was how many times psychedelics were mentioned by Health Canada. He also said that most of the feedback provided to the agency regarding its proposed amendments was positive.
“People are paying to the research…There’s a massive need at the moment. The stigma around psychedelics has come down quite a lot. People are reading the data and recognizing that this could be a potentially massive tool to address this issue we have around mental health.”
Could Health Canada be moving more quickly on the issue of psychedelics now that mental health has been collectively exacerbated by the seemingly never-ending Covid-19 pandemic? Nyquvest said based on what the healthcare system is facing, there is absolutely a greater need for solutions.
“From a micro standpoint, our therapists are busier than they’ve ever been. People are in a bad spot. We see it on the front line. We continue to see a huge amount of inbound interest around psychedelic therapy as well – our inbox is very busy,” he said.
“On a more macro standpoint, most recently, we see the overdose numbers coming out of British Columbia and out of Canada. Overdose numbers are higher than they’ve ever been, suicide rates are high, depression is skyrocketing. We’re in a bad spot; there’s no question about it.”
The SAP was created to help people “in dire need.” Moving forward, Nyquvest said that criteria for patients with mental health considerations should be clarified so that patients aren’t made to try ineffective frontline treatments before they are considered for special access.
“What are the criteria for someone to be in a state where they are in dire need? For psychedelic therapy, we think that needs to be prioritized. We shouldn’t have to guinea-pig someone through three different SSRI treatments if they are in a dire state,” he said.
While Canadians could previously apply for medical use exemptions for psychedelics through Section 56 of the Controlled Drugs and Substances Act, the SAP is accessed by a physician on behalf of their patient and has a turnaround time of 48 hours—a big difference from the long and tedious CDSA exemption process.
Obviously, these changes are huge for patients seeking access, but what do they mean for businesses like Numinus? “The big question is always, how are companies going to generate revenue? With the SAP, it’s a revenue-generating activity, so we’re starting to see these therapies in market,” he said.
“What’s exciting for us is we’ve been ready for over a year to facilitate requests for the SAP. What that also gives us the ability to do is put together better functioning models to hold psychedelic therapy.”
Nyquvest said that for companies that are ready, the SAP presents a significant opportunity.
“It’s not just, ‘we’re going to pop up a location and start giving people MDMA or psilocybin,’” he said. “For us as a company, with the licensing we have to be able to import and export and potentially bring products into market, and then the physical locations to carry out therapy, we answer a lot of questions and help Health Canada a lot with putting together these models. It’s a big opportunity for us, and most importantly, an opportunity to start helping people.”
Watch the rest of the interview to learn more about how Numinus has prepared itself for the new and improved SAP, and how it stands to benefit.
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