The U.S. Food & Drug Administration (FDA) said a CBD-based treatment for opioid use disorder can be used in clinical trials, Ananda Scientific Inc., the drug’s maker, announced this week.
Ananda Scientific said FDA granted an investigational drug designation (IND) for Nantheia ATL5, a liquid administered through the biotech pharma company’s proprietary delivery technology.
The IND approval is the fourth for the Nantheia product line, “and it further re-enforces our vision of developing CBD as a therapeutic for a number of key indications,” said R. Zaidi, ANANDA’s Chief Executive Officer.
Trials at UCLA
“This clinical study at UCLA is an important component of our clinical development efforts focused on opioid addiction, where a non-addictive therapy is a significant unmet need,” Zaidi said of the clinical trial for Nantheia ATL5. To be funded by the National Institute on Drug Abuse, the trial is planned at the Jane and Terry Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles (UCLA).
The trial is being led by principal investigators from the Semel Institute, part of the David Geffen School of Medicine: Edythe London, Ph.D., Distinguished Professor of Psychiatry and Biobehavioral Sciences, and Molecular and Medicinal Pharmacology; and Richard De La Garza II, Ph.D., Professor of Psychiatry and Biobehavioral Sciences. Funding for the trial is from the National Institute on Drug Abuse.
Epidiolex, a THC-free drug that contains high levels of CBD, is the only such medicine fully approved by the FDA. It has proven effective in the treatment of rare forms of epilepsy.
In addition to researching therapies for opioid use disorder, ANANDA Scientific conducts clinical studies evaluating treatment for other conditions such as PTSD, sciatic nerve pain, and anxiety. The company employs patented delivery technology licensed from Lyotropic Delivery Systems Ltd., Israel, to make cannabinoids and other plant-derived compounds bioavailable, water-soluble, and shelf-life stable. ANANDA Scientific said it is expanding its research base through sponsored research agreements with universities to diversify its technology portfolio.
ANANDA Scientific also sells over-the-counter nutraceuticals, having launched such products in the U.S., Australia, and the UK.