CANADA: Tilray has announced that the U.S. Drug Enforcement Administration (DEA) has granted approval to import a cannabinoid study drug into the United States from Canada for a clinical trial at the University of California San Diego (UC San Diego) Center for Medicinal Cannabis Research (CMCR) examining its safety, tolerability and efficacy for Essential Tremor (ET).
Tilray is providing a cannabinoid formulation for the trial in capsule form, which will allow researchers to test an investigational drug product containing two active ingredients extracted from the cannabis plant, cannabidiol (CBD) and tetrahydrocannabinol (THC). 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 Center, will serve as the principal investigator for the study. It is expected to begin in early 2019 with financial support from Tilray and the International Essential Tremor Foundation.
“Tilray is proud to support this crucial research,” says Dr. Catherine Jacobson, Director of Clinical Research at Tilray. “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 is a neurological movement disorder characterized 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.