Earlier this month, the U.S. Food and Drug Administration (FDA) took another step towards recognizing the medical efficacy of cannabis by allowing a new CBD-based drug to advance to the clinical trials phase. Though the name may seem strange, the intended target of Nantheia ATL5 is something sadly familiar to many of us: the opioid crisis.
Helping those suffering from opioid use disorder is the intended purpose of this new investigational drug (IND) from biotech pharma company Ananda Scientific Inc. With approval from the FDA in hand, the next step will be to conduct clinical trials, which are scheduled to get underway in the near future at the University of California, Los Angeles (UCLA).
“This is the fourth IND approval for our investigational drug Nantheiaproduct line,” Zaidi said, “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.”
The IND distinction is crucial, as it exempts companies like Ananda from U.S. federal law requiring that drugs be approved before they can be transported or distributed. With an IND approval from the FDA, however, Ananda will now be able to ship Nantheia ATL5 to the clinical investigators at UCLA for the clinical trials to come.
Physically, the drug reportedly takes the form of soft gel capsules each dosed with 100mg of CBD. Additionally, Forbes details that Ananda licensed a “Liquid Structure technology” from Israeli pharmaceutical company Lyotropic Delivery Systems for their drug as a means of enhancing both the effectiveness and the stability of its featured ingredient.
At UCLA, the clinical trials will be led by principal investigators Edythe London, Ph.D., and Richard De La Garza II, Ph.D., of the Jane and Terry Semel Institute at David Geffen School of Medicine UCLA. Funding for the trial will be provided by the National Institute on Drug Abuse (NIDA).
“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,” Dr. London noted in Ananda’s statement.
Milestone is a perfect choice of words, especially considering that Nantheia ATL5 now stands a chance of becoming only the second CBD-based drug to receive full approval from the FDA.
FOLLOWING IN THE FOOTSTEPS OF EPIDIOLEX
It was 2018 when the FDA made headlines across the world by fully approving a CBD-based drug for the first time. When GW Pharmaceuticals got the ultimate go-ahead from the FDA for Epidiolex — a medicine used to treat the rare epilepsy conditions Lennox-Gastaut syndrome and Dravet syndrome — it unquestionably represented a watershed moment for the future of cannabinoid-based pharmaceuticals.
However, the narrow scope of Epidiolex’s intended use can partially explain why GW Pharmaceuticals was able to succeed where every other drugmaker has, at least thus far, failed. Any treatment for serious epilepsy treatment is going to get fairly unanimous approval, but what comes next?
Ananda Scientific Inc. is hoping they hold the answer. Now the goal is to get the FDA to come around to the idea that CBD may be a viable, if not outright potent, weapon in the battle to curb opioid use by means of offering valid non-addictive alternatives.
We’ll need everything we can get when it comes to amassing an arsenal of aid, as the numbers from the Center for Disease Control and Prevention (CDC) paint an agonizingly grim picture of how bad the situation has become. According to the CDC, close to 841,000 people have died since 1999 from a drug overdose. Of the staggering 70,630 drug overdose deaths that occurred in the U.S. in 2019 alone, 70.6% involved opioids. The scale of the issue is truly massive.
Can CBD be one answer to this problem? It’s a debate with many voices but a CBD drug that can claim full approval from the FDA would likely go a long way towards encouraging a potential mass evolution in perspective on the subject. As proof, look no further than the FDA’s own past warnings, which now seem, at least in part, to reflect a position they no longer hold in wake of their go-ahead on Nantheia ATL5.
BIDDING ADIEU TO THE DARK AGES
As recently as 2019, the FDA was singing a far different tune when it came to the potential of CBD as a treatment for opioid use disorder.
In a fiery letter published in July of that year, the agency issued a stern warning to companies “marketing unapproved cannabidiol products with unsubstantiated claims to treat conditions” that ran the gamut from Alzheimer’s disease to pet anxiety.
Of the claims that garnered the ire of the FDA, one was the suggestion that CBD might be a valid resource in treating opioid use disorder. In its letter highlighting claims the FDA asserts to be “unfounded, unsupported, and unapproved,” they include the following marketing copy as one example:
“CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”
Though the company that posted that specific claim was forced by the FDA to pull it down, perhaps they were ultimately just a little ahead of the curve?
Fast-forward three years and it seems as though the FDA has evolved its thinking, at least when it comes to this particular branch of the tree. Naturally, the best way to amass the research the agency itself acknowledges is pivotal in deciding which CBD-based drugs to approve is to allow that research that takes place.
Though the pace remains slower than many would prefer, the hope now becomes that the IND approval for Nantheia ATL5 will serve as the starting salvo for a new era of exciting research and trials in the field of CBD-based pharmacology.