US federal rescheduling now moves cannabinoid-based products to Schedule III. In our latest Trade To Black podcast, host Shadd Dales sits down with Aras Azatyan, CEO of Avicanna (TSX:AVCN / OTCQX:AVCNF) and Dr. Carolina Urban, Executive Vice President of Scientific and Medical Affairs, to talk about what US hemp realignment could mean for cannabinoid-based medicines. The move could have some profound implications for the Canadian cannabinoid biopharmaceutical company that has spent a decade building to this very moment.
There are three overlapping possibilities created by the rearrangement: increased interest from pharmaceutical and institutional investors now taking cannabinoid therapeutics seriously, the ability to advance clinical programs into US trial sites under a more permissive Schedule III framework, and a higher regulatory bar that rewards companies with established intellectual property and clinical infrastructure;
Azatyan argues that the vast majority of cannabis companies, both in Canada and the US, are not set up for a true pharmaceutical model. Complying with GMP standards, building CMC kits, and conducting phase one to three clinical trials require fundamentally different skills than operating dispensaries or manufacturing consumer products, and the gap cannot be closed quickly with capital alone.
Dr. Urban identified chronic pain and anxiety-related conditions as the most immediate therapeutic targets for the US market under Schedule III. Avicanna’s ongoing Phase II randomized controlled trial for osteoarthritic pain and Phase I THC anxiety study at the University of Calgary as the clearest near-term avenues for co-development partnerships with larger pharmaceutical companies.
Avicanna’s proprietary Qwik rapid-onset nanotechnology platform, designed to increase the rate of absorption and reduce variability in oral cannabinoid delivery, is potentially a ready-to-license vehicle that is well-suited to US pharmaceutical partnerships, especially as prescriptions push out standardized forms of smoking-only medications.
On the international level, Azatyan believes that one thing is true. adult-use cannabis is a domestic market play, while medical and pharmaceutical cannabis is international in nature. He pointed to the company’s Colombian subsidiary as a strategically positioned GMP-compliant supplier capable of serving global markets at competitive prices, with the possibility of one day exporting to the United States itself.
This and more in this episode.