If there is a central issue holding back the expansion of legal medical cannabis in America, it is a perceived lack of research. It is the refrain rising up out of the throats of all opponents to cannabis legalization.
- Lack of research was the reason cited by the Drug Enforcement Administration (DEA) when they declined to reschedule marijuana from Schedule I, the most dangerous category of drugs saved for those with no accepted medical use.
- Insufficient research is also the reason governors and lawmakers in states like Illinois and New Jersey most often give for not moving forward on medical marijuana in their states.
- And a need for research is the reason why the Food and Drug Administration (FDA) doesn’t allow cannabis companies to make medical claims about their products.
If the cannabis industry in America has any faults, it is the impression that there is simply not enough research into the effects of marijuana.
However, this seems hard to swallow for many cannabis advocates since there are tens of thousands of studies and reviews posted to PubMed under keywords like cannabis, cannabinoids, and marijuana.
Published medical research on cannabis has ballooned from 131 published articles in 1996, the year California became the first to legalize medical marijuana, to 1,132 so far in 2016. These numbers are continuing to trend upwards as marijuana gains in popularity. Currently, nearly 90% of American voters support medical marijuana.
Opponents of medical marijuana have a very specific type of research in mind when they decry the need for more. What lawmakers, health officials, and critics mean when they discuss a need for research are placebo controlled, double blind human clinical trials. These types of clinical trials are the gold standard of medical research and an important step in the creation of any new drug.
Few cannabis companies are moving forward with these types of tests, though, or even working toward them, because they can be prohibitively expensive. AXIM Biotechnologies®, however, is pursuing just the type of research needed. The Medical Marijuana, Inc. portfolio company is currently undertaking clinical trials on a pair of its products with the possibility of seeking approval for new drug status.
AXIM Biotechnologies® is working on human clinical trials for a cannabigerol (CBG) based topical as a treatment for psoriasis and eczema. CBG is not considered psychoactive and is not specifically scheduled in either international or U.S. regulations restricting cannabis, making it a strong alternative to traditional treatments without the side effects of THC-based medications.
This proof of concept trial for their product, designated AX-1602, will either lead to the topical being presented as an over-the-counter cosmetic product or file a new drug application (NDA) with the FDA and enter into further clinical trials, depending on the outcome.
The company is also working on clinical trials for its combined CBD/THC chewing gum, MedChew RX™. AXIM Biotechnologies® has a patent on cannabidiol-infused chewing gum products as a delivery system. MedChew RX™ is being tested for the treatment of the pain and spasticity associated with multiple sclerosis.
The product is on track to be fully registered by the European Medicines Agency (EMA). Once it is approved by the EMA, it will be available for use across the European Union. AXIM Biotechnologies® is also petitioning the FDA to grant them an accelerated development timeline, possibly allowing them to accelerate the approval process for the use of MedChew RX™ in the U.S.
Looking forward, AXIM Biotechnologies® is developing the further use of cannabinoids to create pharmaceuticals and treatments for conditions with no known current effective treatments: such as, Parkinson’s disease, Alzheimer’s disease, ADHD, PTSD, autism, restless leg syndrome, glaucoma, IBD and IBS, and Crohn’s disease.
AXIM Biotechnologies® clinical trials will continue to provide critics of medical marijuana with the research they need to move toward the effective use of cannabis-based medications and whole plant treatments in the U.S. and internationally.
As cannabis re-enters the U.S. pharmacopeia, it will be companies like Medical Marijuana, Inc. investment AXIM Biotechnologies® undertaking clinical trials for their products that will help secure the reputation of cannabis as an effective medicine, finally giving skeptics the research they’ve requested.