Flora Growth is seeking Emergency Use Authorization in Colombia for a cannabis-based product aimed … [+]
Flora Growth announced this week that they will be seeking Emergency Use Authorization, under Covid-19 protocols in Colombia, for a cannabis-based product. Aimed at preventing Covid-19 infection, Flora Growth’s formula would be the first cannabis based product to be approved for use against Covid-19 in Colombia. The International cannabis company’s patent-pending formula has been submitted to the USPTO, and studies have been completed showing the drug’s safety and bioavailability.
Still, it is important to note that clinical trials showing efficacy against Covid-19 have not been done. Instead, Flora Pharma (Flora Growth’s research division) is beginning talks with INVIMA (the FDA of Columbia) to plan out a study that would investigate the mechanisms by which cannabinoids might prevent infection from Covid-19, and show whether their cannabinoid-based product can really accomplish this goal.
“We are honored to receive the advice and guidelines from INVIMA as we begin this exciting research process. The Flora Pharma division seeks to obtain evidence to support this product’s use against SARS-CoV-2 and bring to market an effective, cannabinoid-based product,” explains Luis Merchan, President and CEO of Flora Growth.
Dr. Annabelle Manalo-Morgan, scientist and head of Flora Pharma says that “The intent of the study is to identify safe and efficacious cannabinoid products for use on SARS-CoV-2 thus allowing us to pursue the fastest path to market via a preventative immunomodulating product and to explore the possibility of use as a therapeutic.”
This news comes right after a few important studies came out suggesting certain compounds in cannabis may have potential to aid in Covid-19 prevention. One recent study from University of Chicago reported that the cannabinoid CBD was able to inhibit viral replication of Covid-19 in lung cells, in studies on human cells and mice. A related study found that patients who were already using large amounts of CBD (but not THC) had significantly lower rates of Covid-19.
Another recent study from Oregon State University reported certain acidic cannabinoids were able to prevent human cells from being infected with Covid-19 in lab studies. Hana Rexroth, a representative from Flora Growth, explained that while they would “not be focusing on the cannabinoid acids alone in our studies, we will be following up on that study with the intention of adding more layers to their great research.”
While these studies do suggest potential for a cannabis based formula to assist with Covid-19 prevention, it is important to note that these studies were all done in labs on cells, or were population based studies, rather than in human clinical trials. And they were done on compounds from cannabis, rather than cannabis itself.
If you are thinking that this research suggests the average cannabis smoker is better off when it comes to Covid-19, think again. The above study on CBD found that the protective effects diminished when THC (a plentiful psychoactive chemical in most cannabis) was added. And some studies show higher rates of infection and worse outcomes in Covid-19 for cannabis users who meet the criteria for cannabis dependence. Smoking cannabis, in particular, may open up additional risk factors since it can negatively impact the lungs.
The product Flora Growth is hoping to get approved in Columbia for use against Covid-19 is non-psychoactive (and thus doesn’t contain THC), and would be ingested orally. If approved, it would likely be covered by insurance – since Colombia recently passed legislation requiring insurance companies to cover cannabis-based prescriptions.