Canadian marijuana producer Tilray Inc. says it has received approval from the U.S. Drug Enforcement Administration agency to export a medical cannabis product south of the border for use in a clinical trial. Tilray President Brendan Kennedy is photographed at head office in Nanaimo, B.C., on Thursday, November 29, 2017. THE CANADIAN PRESS/Chad Hipolito
Tilray gets DEA-approval to send cannabinoid capsules to USA for Clinical Trial at UC San Diego Center
U.S. Drug Enforcement Administration approves import of a pharmaceutical-grade medical cannabis product produced by Tilray into the United States for a clinical trial focused on Essential Tremor
NANAIMO, B.C. – Tilray Inc. today 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.
“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 Dr. 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.”
“We are extremely enthusiastic about the initiation of this study, extending as it does CMCR’s program to discover therapeutic potential of various cannabinoid preparations,” said Dr. Igor Grant, Center for Medicinal Cannabis Research Director. “These studies are promising to uncover new treatments for difficult to treat conditions.”
“The IETF is proud to provide grant funding for this study which provides hope to the essential tremor community,” said Patrick McCartney, executive director of the International Essential Tremor Foundation. “The effectiveness of cannabis as a treatment for essential tremor has long been a topic of interest in the ET community. We are grateful to Dr. Nahab and UC San Diego Center for Medicinal Cannabis Research for their dedication to scientific research of this kind. And we commend Tilray for the development of this study drug which has the potential to help thousands of people who struggle with ET.”