The Food and Drug Administration (FDA) in America has given approval for an Investigative New Drug (IND) application for proposed human trials by biotech company ANANDA Scientific. The trials are set to test their experimental drug Nantheia ATL5 for its efficacy in the treatment of opioid addiction.
Nantheia is a patented CBD delivery system designed by ANANDA to increase the bioavailability of CBD in the body. Ananda’s website says, “The importance of being able to make CBD water soluble and to otherwise get it efficiently, predictably and economically into the bloodstream cannot be overstated. It is crucial for making CBD realize its profound therapeutic potential. The problem has been distinctively resolved by ANANDA Scientific via its unique, patent-protected “Liquid StructureTM” technology. It turns CBD (as well as other problematic plant-derived substances) into exceptional nutraceutical and pharmaceutical products that really work.“
The US is currently experiencing a record number of opioid deaths. Data gathered by the Centers for Disease Control and Prevention (CDC) at the end of last year showed that more than 53,000 opioid-related deaths were reported in 2021. Commenting on the trials approval ANANDA CEO Sohail Zaida said “This is the fourth IND approval for our investigational drug Nantheia product line, and it further re-enforces our vision of developing CBD as a therapeutic for a number of key indications. 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. We are excited to be working with the UCLA team and look forward to this trial advancing.”
In a statement issued on January 4th, ANANDA said the trials would be led by Dr Edythe London and Dr Richard de la Garza of the Jane and Terry Semel Institute at David Geffen School of Medicine UCLA. Funding for the trial has been provided by the National Institute of Drug Abuse (NIMA).
Dr London said, “The approval of the IND for this important clinical trial is a key milestone for our ongoing research into therapeutic alternatives for opioid use disorder and reversal of the effects of the opioid epidemic.”
At present, the only plant-derived FDA approved drug containing CBD is Epidiolex, which is produced in the UK by GW Pharmaceuticals. GW was purchased in a huge $7.2 billion deal early last year. Epidiolex treats two rare forms of epilepsy in children over two years old, Lennox-Gastaut syndrome and Dravet syndrome.