On a brick background, a neon sign in red and blue light that reads STOP THE OPIOID CRISIS GETTY
U.S. Food and Drug Administration approved an application for an investigational new drug, (IND), to conduct a clinical trial that will evaluate CBD as an adjunctive treatment to opioid abuse disorder.
Ananda Scientific Inc., a biotech pharma company, announced the FDA approval in January 2022 for the clinical trial evaluating Nantheia ATL5, a drug that uses CBD as an adjunctive therapy for opioid use disorder. The University of California, Los Angeles will conduct the study.
Nantheia ATL5 contains 100mg CBD in each soft gel capsule. It is an oral product that uses Liquid Structure technology licensed by Lyotropic Delivery Systems Israel, which increases the stability and effectiveness of CBD.
Initial clinical and pre-clinical studies have shown that ANANDA’s Liquid Structure technology would increase the stability and effectiveness of CBD.
The company claims that this innovation could open up new opportunities for CBD therapeutics. It may be able to lower opioid intake for patients who are addicted or treated with opioids.
The federal law currently states that a drug must be approved prior to being transported or distributed in the United States. The FDA can however approve an IND request, which allows the company to exempt it from this rule and allow it to ship the investigational drugs to clinical investigators in other U.S. States.
The FDA states that the primary goal of a sponsor during preclinical development for a drug is to establish if it is safe to use in humans and whether the compound has pharmacological activity sufficient to justify commercial development. Only when the product is considered an ideal candidate for further development, can the company collect the necessary data and information to determine the impact on human health.
Dr. EdytheLondon, one of the principal investigators in the trial, stated that approval of the IND to Ananda’s clinical study is a significant milestone in ongoing research into alternative treatments for opioid addiction and reversal.
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The Centers for Disease Control and Prevention reports that nearly 841,000 people have died from drug overdoses since 1999. More than 70% of all drug overdose deaths in 2019 were caused by opioids.
Pre-clinical animal research by Dr. Yasmin Hrud, Ward-Coleman chair in Translational Neuroscience, and Director of Mount Sinai’s Addiction Institute, showed that CBD reduces heroin-seeking behavior in opioid-use disorder patients.
The debate about CBD as a treatment for the opioid crisis remains divisive. Some believe cannabis could be an alternative to opioids to treat chronic pain, and reduce overdoses and deaths. Others argue that cannabis could help people suffering from opioid addiction to quit using opioids.
Two companies were issued warning letters by the FDA in 2020 for illegally selling CBD products that had not been approved. These violations violated the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Amy Abernethy, FDA Principal Deputy Commissioner, stated in a press release that “the opioid crisis remains a serious problem in America” and that she will continue to pursue companies that profit from products with unfounded claims of treatment.
Unapproved CBD products that are not FDA-approved have many questions.
The FDA has approved Epidiolex, a THC free drug containing high amounts of CBD, only once. It was developed by GW Pharmaceuticals. It has been proven to be effective in the treatment of two severe and rare forms of epilepsy (Lennox-Gastaut and Dravet) in patients aged two years and older.