FDA Thumbs-Up For Opioid Use Disorder Cannabidiol Trial

Colorado-headquartered biotech pharma company Ananda Scientific says it has been approved by the FDA to kick off a clinical trial evaluating CBD in treating Opioid Use Disorder.

Between 1999–2019, close to 500,000 Americans died from an overdose involving prescription and illicit opioids. In 2020 alone, there were 69,710 deaths – the highest level since at least 2015; and by quite a margin.

We’ve often reported on the potential for medicinal cannabis to play a role in addressing the opioid scourge, both in terms of replacing such prescription drugs and in managing withdrawal in those who unfortunately become dependent. It’s encouraging to see that research is continuing.

Ananda Scientific announced in October 2021 its intention of carrying out a clinical trial to evaluate Nantheia ATL5 – an investigational drug containing cannabidiol (CBD) – as an adjunctive treatment for Opioid Use Disorder.

Nantheia ATL5 uses the company’s proprietary Liquid Structure as the delivery technology. Ananda claims its Liquid Structure tech greatly improves bioavailability of CBD in the body. Bioavailability is the ability of a substance to be absorbed and utilised by the body.

“With Liquid Structure CBD, almost 20x more reaches the bloodstream in 30 minutes,” states Ananda Scientific.

CBD is an expensive substance, so the less needed to achieve a therapeutic effect, the better. If CBD does prove useful in as an adjunctive treatment for Opioid Use Disorder, Liquid Structure could help deliver more rapid desired effects.

One of the hurdles Anadanda Scientific has had to clear before starting the trial is having its Investigational New Drug (IND) application approved by the U.S. Food and Drug Administration (FDA) – and that’s now occurred.

The study is to be carried out at the Jane and Terry Semel Institute for Neuroscience and Human Behavior 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,” said Ananda CEO Sohail R. Zaidi. “We are excited to be working with the UCLA team and look forward to this trial advancing.”

Richard De La Garza II, Ph.D., Professor of Psychiatry and Biobehavioral Sciences at the Institute, said with the IND now approved, the team is moving quickly to get the clinical trial under way.

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