The U.S. Food and Drug Administration has given the OK to begin human trials for a CBD-based drug intended to support recovery from opioid addiction, reports Hemp Industry Daily.
The drug, Nantheia ATL5, was developed by Ananda Scientific and will be tested at the University of California, Los Angeles. Funding will come from the National Institute on Drug Abuse.
“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 Sohail R. Zaidi, Ananda’s chief executive officer in a news release. “We are excited to be working with the UCLA team and look forward to this trial advancing.”
“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 R. Zaidi, Chief Executive Officer, Ananda Scientific
Ananda is a biotech company focused on developing plant-based therapies for post-traumatic stress disorder, anxiety, opioid addiction and pain from pinched nerves. The company says it uses proprietary technology to increase bioavailability of cannabinoids and other plant compounds. (Ananda is Sanskrit for "bliss" and presumably a nod to anandamide, part of the body's endogenous cannabinoid system.)
CEO Zaidi said the approval to move forward with testing “further re-enforces our vision of developing CBD as a therapeutic for a number of key indications.”
The approval to test is significant in part because the FDA has been hesitant to regulate CBD and other cannabinoids as food or dietary supplements, leaving only a highly-regulated window of opportunity for cannabis extracts to be approved as drugs.
The approval to test is significant in part because the U.S. Food and Drug Administration has been hesitant to regulate CBD and other cannabinoids as food or dietary supplements, leaving a narrow window for such products to be approved as drugs.
So far, few companies have tried this route. Only one CBD-based medication has been approved by the FDA: Epidiolex, an anti-seizure treatment for rare forms of epilepsy. And its approval has complicated the issue for those seeking regulation as a supplement.
In August 2021, the FDA shot down two proposals from companies seeking to have their full-spectrum CBD extracts regulated as dietary supplements: Charlotte’s Web and Irwin Naturals. In rejecting them, the FDA noted that CBD is the active ingredient in Epidiolex, and because it's a drug it can't be marketed as a dietary supplement.
And, Hemp Industry Daily pointed out, the approval to test Nantheia ATL5 suggests that companies forced to silence statements about CBD’s potential effects might not have been wrong about the cannabinoid’s impacts. “The clearance comes two years after the FDA issued a warning letter to Massachusetts-based Curaleaf for marketing its CBD product’s potential to treat opioid addiction,” the hemp news site noted.
However, the saga of FDA regulation and approval continues to evolve. Several bills were introduced to federal lawmakers in 2021 that, if approved, would enable or even require the FDA to begin regulating CBD as a food additive and dietary supplement.
