The 2nd International Congress on

Clinical Trials on Cannabis

Cannabis has been part of countless civilizations, with references in ancient cultures spanning thousands of years. Within the United States, cannabis has had a rather storied past, from its inclusion within the US Pharmacopeia in 1850, allowing physicians to prescribe it for any condition, to its placement in the most restrictive category of the Controlled Substances Act in 1970, where it remains today. Generally, data regarding the impact of cannabis have largely been derived from observational studies of recreational consumers or acute administration studies, which in the US, used products exclusively sourced from the National Institute on Drug Abuse (NIDA). Despite a re-legalization for medical purposes in California in 1996, studies of medical cannabis patients, while expanding, remain extremely limited, with no long-term data available. Accordingly, in 2014, Dr. Gruber founded the Marijuana Investigations for Neuroscientific Discovery (MIND) program, specifically designed to examine the long-term impact of medical cannabis use on a range of health-related outcomes using various methodological approaches, including clinical trials. Dr. Gruber will highlight some of the difficulties she and her team faced while working towards conducting the first FDA-approved clinical trial of a whole-plant, full-spectrum, cannabis-derived product for anxiety and related symptoms. Despite initial obstacles, this study is well underway; Dr. Gruber will present recently published data from the open-label phase of the study and discuss the ongoing double-blind, three arm trial. In addition, she will discuss other ongoing and soon-to-launch clinical studies from the MIND program and explain why clinical trials may continue to be a “gold standard” for research, but must also include data from real world patients using real world products via comprehensive, multidimensional observational studies.

The field of cannabinoid research is advancing, with new discoveries being made about the potential therapeutic benefits of these compounds. However, for these discoveries to be translated into effective treatments for patients, it is essential that proper due diligence is done, and well-designed clinical trials programs are initiated. In this presentation, we will discuss the course, challenges, considerations, and rewards for advancing the cannabinoid scientific research landscape

The course – why should we care enough to pioneer the scientific research landscape

The challenges – why is it only the courageous that pursue this new medical frontier

The considerations to minimize risk and inform sound investment decision making

The rewards – Is it worth it?

Despite the promising potential of cannabinoids, there is still a need for more rigorous scientific research to fully understand their therapeutic benefits.

Discover why the time is right and the time is now.

Cannabidiol (CBD) is fast emerging as an exciting ingredient across the pharmaceutical market, powered by increasing scientific research investigating its potential benefits in a number of disease states, including central nervous system (CNS) disorders, pain management, cancer and more. While there is a remarkable opportunity for the development of CBD-based therapies in the field, formulating a highly lipophilic API (logP = 6.3) and poorly soluble crystalline API can be a challenging task, especially when the focus is on increasing the oral bioavailability of the molecule.

Oral bioavailability – simply defined – is a measure of the quantity of drug absorbed into the systemic circulation following oral administration of the drug. The oral bioavailability of CBD has been shown to be very low in humans, as a result of incomplete absorption in the gut and significant pre-systemic elimination in the liver. It is therefore paramount to understand and control these inherent obstacles in order to address the challenge of bioavailability when formulating CBD.

With this in mind, the objective of this work was to systematically explore a number of drug delivery technologies, previously claimed to possess the ability to enhance the bioavailability of poorly soluble drugs and assess their effectiveness in increasing the pharmacokinetic profile of CBD. By using a combination of powder characterization techniques (e.g. DSC, XRD, DLS), in-vitro assays and animal models we strived to correlate the physical properties of the differently formulated API with its in-vitro bioaccessibility profile and eventually its in-vivo pharmacokinetic performance.

We expect that the currently ongoing in-vivo evaluation will further help us elucidate the correlation between the deliberate choice of excipients and formulation technology and the pharmacokinetic performance of the API, enabling us to choose the right candidates for clinical validation and eventual product development.

The end results of our research will not only help improve the oral bioavailability of CBD, but also inform the pharmaceutical industry on the appropriate formulation for their intended applications, thereby enabling the industry to explore and expand upon the established therapeutic benefits of CBD more effectively.