FDA Approves IND Application for CBD Product Nantheia ATL5

The FDA has approved the investigational new drug (IND) application for the clinical trial evaluating Nantheia ATL5 (Ananda Scientific), an investigational drug using cannabidiol (CBD) as an adjunctive treatment for opioid use disorder (OUD).¹

Nantheia ATL5 is made from Ananda’s Liquid Structure technology, licensed from Lyotropic Delivery Systems, which enhances the effectiveness and stability of CBD.²

It creates new potential for CBD therapeutics, such as the ability to reduce opioid intake for individuals being treated for OUD and facilitating voluntary opioid sparing.

The drug is an oral medication with 100 mg of CBD per soft-gel capsule.³

“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,” Sohail Zaidi, CEO of Ananda, said in a statement.¹

The study will be conducted at the Jane and Terry Semel Institute for Neuroscience and Human Behavior at the University of California in Los Angeles.

The trial will be led by investigators, Richard De La Garza, PhD, professor of psychiatry and biobehavioral sciences at the Jane and Terry Semel Institute, and Edythe London, PhD, professor of psychiatry and biobehavioral sciences and molecular and medicinal pharmacology at the Jane and Terry Semel Institute.

“This clinical trial with Nantheia ATL5 has the possibility to advance applications for CBD in ANANDA’s patented delivery technology in an area that could positively impact the lives of a large number of people suffering from opioid addiction. Opioids are a huge driver of overdose deaths in the U.S. and a non-addictive therapy is a significant unmet need,” Zaidi said in a statement.³

About 841,000 individuals have died from a drug overdose since 1999, and more than 70% of drug overdose deaths in 2019 involved an opioid, according to the CDC.⁴

Overdose deaths involving opioids including heroin, prescription opioids, and synthetic opioids, such as fentanyl, have increased more than 6 times since 1999.⁴

Reference

1. Ananda Scientific announces FDA approval of the IND for the clinical trial on the treatment of opioid use disorder (OUD). Business Wire. News release. January 4, 2022. Accessed January 5, 2022. https://www.businesswire.com/news/home/20220104005104/en

2. Ananda Scientific and the David Geffen School of medicine UCLA announce a clinical trial utilizing liquid structure cannabidiol (CBD) for the treatment of opioid use disorder (OUD). Ananda Scientific. News release. Accessed January 5, 2021. https://www.anandascientific.com/ananda-scientific-and-the-david-geffen-school-of-medicine-ucla-announce-a-clinical-trial-utilizing-liquid-structuretm-cannabidiol-cbd-for-the-treatment-of-opioid-use-disorder-oud/

3. Ananda Scientific’s liquid structure cannabidiol (CBD) to be clinically evaluated for opioid use disorder. Business Wire. News release. October 19, 2021. https://www.businesswire.com/news/home/20211019005004/en/

4. The drug overdose epidemic: behind the numbers. CDC. March 25, 2021. Accessed January 5, 2022. https://www.cdc.gov/opioids/data/index.html