Import of pharmaceutical grade medical cannabis produced by Tilray® Inc has been approved by the U.S. Drug Enforcement Administration (DEA), with a special study focus on essential tumour.
Tilray has announced the approval of importing a medical cannabis study drug from Canada into the United States for a clinical trial held at the University of California San Diego. The study is to examine its safety, tolerability and usefulness for essential tremor (ET).
The cannabinoid formulation is to be provided in capsule form, therefore allowing researchers to test an investigational drug product containing two active ingredients extracted from the cannabis plant, cannabidiol and tetrahydrocannabinol.
The study is expected to begin in early 2019, with the principle investigator being Dr. Fatta Nahab, a board-certified neurologist and director of the Functional Imaging of Neurodegenerative Disorders Lab at the UC San Diego health’s movement disorder centre.
“It’s exciting to advance our work in this area by conducting a first-of-its kind trial of purified medicinal cannabis for a common neurological disorder like essential tremor,” says Nahab. “Until now patients have been on their own to figure out the efficacy, safety, and dosing of cannabinoids. This trial should help answer many of these critical questions.”
With financial support from Tilray and the International Essential Tremor Foundation, Dr. Catherine Jacobson, director of clinical research at Tilray says: “Tilray is proud to support this crucial research”.
“If this study can identify cannabinoids as a potential treatment for patients suffering from essential tremor, we can conduct further research and potentially provide alternative effective methods of relief for the high numbers of patients with ET.”
Essential tremor key facts
Essential tremor is a neurological movement disorder characterised by involuntary and rhythmic shaking. ET has extremely high prevalence rates; 0.4% of the general population suffer from ET, and that figure rises to 4.6% to 6.3% among those 65 and older. Essential Tremor can have a significant impact on a patient’s quality of life, causing embarrassment, social withdrawal, disability, and loss of occupation. Many patients do not experience relief with the current drugs on the market or find the side-effects of these drugs to be unbearable.