Global Clinical Research and Drug Safety Program


Global Clinical Research and Drug Safety Program

This article was originally published on the Spectrum Therapeutics Canada site.

As patients worldwide struggle with unmet medical needs in the management of their pain, mood, anxiety, and sleep disorders, there is a need for safe treatment options that have been clinically tested. To this end, Spectrum Therapeutics is engaged in clinical trial research to evaluate cannabinoid-based medicines that meet these needs.

Clinical research

Spectrum Therapeutics is conducting research that includes the testing of standardized cannabis formulations and dose-delivery systems for safety and efficacy in various disease indications.

Our clinical studies of cannabinoid-based medicines cover a range of THC and CBD ratios and will provide critical dosing and safety data to inform clinical practice. The first early phase human clinical trial to test medical cannabis as a treatment for insomnia is underway in partnership with Drs. Julie Carrier and Alex Desautels at the Université de Montréal. Study completion and results are expected in early 2021.

Other studies are currently underway in partnership with Dr. Bernard Le Foll at the Centre for Addiction and Mental Health, Dr. Mary-Ann Fitzcharles at McGill University, and Dr. Angela Genge at the Montreal Neurological Institute. More than 20 conditions are being examined across these studies, including pain, sleep, and mood/anxiety disorders.

An exciting avenue of exploration is our research partnership with the NHL Alumni Association evaluating the efficacy of CBD-based therapies as part of a treatment for concussion symptoms. This clinical trial is expected to register its first patients in October 2019 with initial data in July 2020.

Our fully owned subsidiary, C3 Cannabinoid Compound Company, has a clinical trial for the use of dronabinol—a synthetic version of THC—to treat spasticity in multiple sclerosis. C3 brings nearly 20 years of research, innovation, and a commitment to supporting European doctors with the data they need to prescribe synthetic and natural cannabis products to their patients.

In September, Spectrum Therapeutics will begin registering patients in a European study on the potential of cannabinoid-based medicines to treat cancer-related pain.

Led by a recognized team of experts

Spectrum clinical research is led by globally renowned leaders with a wide range of expertise. 

Dr. Marcel Bonn-Miller is the Global Clinical Scientific Director at Spectrum Therapeutics and an adjunct assistant professor at the University of Pennsylvania Perelman School of Medicine. He is known for his work examining the potential of cannabis to treat post-traumatic stress disorder. Bonn-Miller is supported by Hunter Land, who was instrumental in bringing the first cannabis-derived CBD medicine—Epidiolex for pediatric epilepsy—through FDA approval.

Company-wide drug safety reporting

Spectrum Therapeutics is committed to patient safety and good clinical practice. Our global drug safety program captures and documents adverse events reported from the use of our medical cannabis products. This database of information will further advance our understanding of cannabis safety.

Drug safety—also known as pharmacovigilance—involves the detection, assessment, understanding, and prevention of adverse events related to the use of pharmaceutical products. While Spectrum Therapeutics was already reporting any adverse reactions to its cannabis products as per Health Canada regulations, the launch of our global pharmacovigilance program expands this effort further and positions Spectrum as a leader in its collection of safety data.

By developing new cannabinoid-based medicines, testing these for safety and efficacy through clinical trials, and monitoring their use in the real world, Spectrum Therapeutics is committed to serving unmet medical needs in pain, mood, anxiety, and sleep disorders.