LEAMINGTON, Ontario – Tilray Medical, a division of global cannabis leader Tilray Brands, Inc. (NASDAQ: TLRY), has released findings from a significant scientific study shedding light on the pharmacokinetics of two different cannabinoid formulations. The research, a pilot crossover pharmacokinetic study, compared the bioavailability of an oral Tilray THC:CBD extract against an oromucosal spray formulation known as nabiximols.
The study involved a cohort of twelve healthy volunteers, equally split between six men and six women. Participants were assessed under strictly controlled fasting conditions to minimize external variables affecting absorption.
Study Design and Methodology
The rigorous crossover design meant that each participant received both formulations at different times, allowing for direct comparison within the same individual. This approach enhances the reliability of the findings regarding how the body processes the cannabinoids.
Specifically, volunteers were administered one of two treatments:
1. A 1 mL oral dose of the Tilray extract. This formulation contained a concentration of 10 mg/mL each of D9-tetrahydrocannabinol (THC) and cannabidiol (CBD), resulting in a total dose of 10 mg THC and 10 mg CBD.
2. Four sprays of nabiximols. This oromucosal spray delivered a total dose of 10.8 mg THC and 10 mg CBD.
Following administration, blood samples were collected over a comprehensive 24-hour period. These samples were analyzed to meticulously measure the concentrations of THC, its primary psychoactive metabolite 11-OH-THC, and CBD circulating in the bloodstream over time. Key pharmacokinetic parameters evaluated included peak concentration (Cmax), time to reach peak concentration (Tmax), and overall drug exposure (measured by the area under the curve, or AUC).
Key Findings on Bioavailability
The results of the study indicated notable differences in how the two formulations were absorbed and processed by the body, particularly concerning peak cannabinoid levels.
* Peak Concentrations (Cmax): The oral Tilray THC:CBD formulation produced significantly higher peak concentrations (Cmax) for both THC and CBD compared to the nabiximols oromucosal spray. This suggests that while the oral route may lead to a slower onset of effects due to first-pass metabolism, it can ultimately deliver a higher maximum concentration of cannabinoids into the systemic circulation.
* Time to Peak (Tmax) and Overall Exposure (AUC): Despite the difference in Cmax, the study found no significant differences in the time taken to reach peak concentration (Tmax) or the overall extent of exposure (AUC) between the two formulations for the group as a whole.
* Gender Differences: An interesting finding was observed with the nabiximols formulation, where the peak concentration (Cmax) was significantly higher in male participants compared to female participants. This highlights potential physiological differences in how sexes absorb or process cannabinoids administered via the oromucosal route.
* Drug Levels Over Time: The study also tracked cannabinoid presence over a full day. After 24 hours, both THC and CBD were found to be undetectable in the blood samples across participants. Concentrations of 11-OH-THC, the active metabolite, were significantly reduced by this time point.
Safety Profile and Adverse Events
The study also monitored for adverse events. Importantly, the research reported that no serious adverse events occurred in any of the twelve healthy volunteers during the course of the study.
Implications for Patient Care
The differing pharmacokinetic profiles observed in this study have potential implications for how medical cannabis formulations are chosen and utilized to optimize patient outcomes. The finding that the oral formulation can deliver higher peak concentrations of THC and CBD suggests it might be beneficial for patients who require a more pronounced or potentially faster-acting effect once systemic absorption occurs.
According to Dr. José Tempero, Medical Director at Tilray Medical, the findings from this pilot study are significant. He stated, “Our findings suggest that the oral formulation may potentially deliver cannabinoids more efficiently into the bloodstream compared to the oromucosal spray, potentially benefiting patients requiring faster or more pronounced effects. While a pilot study, these initial pharmacokinetic insights are valuable.” Dr. Tempero’s comments underscore the importance of understanding formulation differences in clinical practice.
Company Perspective on Advancing Research
The publication of this study reinforces Tilray Medical’s stated commitment to rigorous scientific investigation in the field of medical cannabis. Denise Faltishchek, Tilray’s Chief Strategy Officer and Head of International, commented on the company’s dedication to advancing the understanding of cannabinoid-based medicines.
Ms. Faltishchek stated, “This research exemplifies Tilray’s commitment to advancing the scientific understanding of medical cannabis and developing evidence-based products for patients worldwide. Investing in pharmacokinetic studies like this is crucial as we continue to explore how different delivery methods impact the body’s absorption and utilization of cannabinoids.” Her statement highlights the strategic importance Tilray places on research to inform product development and clinical use.
This study provides valuable pharmacokinetic data comparing two common administration routes for THC and CBD formulations, contributing to the growing body of scientific evidence guiding the clinical application of medical cannabis.
