Cannabis-based medications have the potential to transform healthcare in the coming years.
Although medical marijuana has existed in the U.S. since 1996 when it was first legalized in California, in many ways cannabis and its cannabinoids are still locked out of the traditional healthcare market in many ways.
Despite extensive research into the beneficial effects of cannabinoids, the DEA continues to classify marijuana as a Schedule I drug, meaning it has no recognized medical uses. However, as more information has become available, astute companies are starting to develop ways to integrate cannabinoids into the healthcare system, including dietary supplements, over-the-counter or OTC products, and prescription medications.
Companies, like Medical Marijuana, Inc. subsidiary HempMeds®, are working to bring cannabinoids to the world through the retail of CBD hemp oil daily supplements, like their Real Scientific Hemp Oil™ and Dixie Botanicals® brands.
Since the start of prohibition, the human population has been deficient of cannabinoids, starving our endocannabinoid system. These CBD hemp oil supplements offer a full-spectrum cannabis oil that provides the body with a number of active cannabinoids, which then interact with our native endocannabinoid systems.
In the face of ongoing federal prohibition, these CBD hemp oil products are the only 100 percent legal source of cannabinoids in the U.S. and in many international countries.
Drugs that do not require a doctor’s prescription and are bought off the shelf in pharmacies, grocery stores, and convenience stores are called over-the-counter drugs. OTC drugs tend to have a larger safety margin than prescription medicines, minimizing negative side effects and the chance of overdose.
These drugs follow a standard set of FDA approved regulations, including ingredients, doses, formulations, and labeling, that are called monographs. Products adhering to an existing monograph can be marketed without further FDA clearance. However, if no monograph has been created for a particular drug, then the product must be approved through the FDA’s “New Drug Approval System”.
Cannabinoids may soon be developed into non-prescription, over-the-counter treatments. As biotech businesses like Medical Marijuana, Inc. investment company AXIM® Biotechnologies create novel new treatments and begin clinical trials geared toward FDA approval, the companies may have the option of releasing their products as over-the-counter products.
Finally, cannabinoids have made their way into the healthcare industry in the form of cannabis-based pharmaceuticals. These drugs need to go through the New Drug Application process, just as any other new pharmaceutical must.
Once approved by the FDA, cannabis-based pharmaceuticals enjoy the same benefits as other new drugs, including market exclusivity. While marijuana is still classified as a Schedule I drug by the DEA, when specific new cannabinoid-based drugs are approved by the FDA, they are then listed in a lower classification.
An example of this is Marinol, a cannabinoid-based medication approved for wasting syndrome (Cachexia) and nausea for HIV/AIDS and cancer patients. Containing a synthetic form of THC, Marinol is a Schedule III drug.
Late last year, AXIM® Biotechnologies, a Medical Marijuana, Inc. investment company, just recently received the funding needed to pursue multiple clinical trials on cannabinoid derived drugs.
The company’s cannabinoid-infused chewing gum MedChew® RX is being prepared for trials for the pain and spasticity associated with multiple sclerosis. The study is scheduled to take 12 months and should be followed by FDA/EMA registration as a novel treatment for MS.
AXIM® is also running clinical trials on its CanChew® Plus cannabinoid chewing gum to determine the formulation’s potential as a treatment for Irritable Bowel Syndrome (IBS). The company just completed its PK/PD study testing two different potencies of CanChew® gum to choose the ideal dosing for their next phase of trials.
Finally, AXIM® Biotechnologies is pursuing clinical studies on its proprietary topical cannabinoid application, AX-1602. AXIM® plans to test AX-1602 for the treatment of psoriasis and eczema. The company’s patent pending topical is made using cannabigerol or CBG, known as the “stem cell cannabinoid” for its ability to become any other cannabinoid.
Another of Medical Marijuana, Inc.’s investment companies, Kannalife™ Sciences is also working to develop novel new treatments derived from cannabinoids. Using their licenses on the government’s patent 6,630,507, Cannabinoids as antioxidants and neuroprotectants, Kannalife™ Sciences is developing cannabinoid-based medications for a pair of degenerative brain conditions, hepatic encephalopathy and chronic traumatic encephalopathy.
Hepatic encephalopathy (HE) appears when the liver cannot function properly, allowing toxins to reach the brain, damaging functionality. HE typically occurs in those with chronic liver disease and can be caused by abuse of alcohol and prescription medications.
Chronic traumatic encephalopathy (CTE) is the result of repeated blows to the head. Linked to concussions, CTE is estimated to affect over 90% of NFL players, but may be found in anyone with head injuries.
Although Kannalife™ Sciences is focusing on these two conditions in their research now, the company’s work can result in treatments for a number of other neurodegenerative diseases, like Alzheimer’s disease and Parkinson’s disease.
As the benefits of cannabinoids continue to find their way into the healthcare system, the availability of cannabis-based products will increase. Further research and acceptability of cannabis as a treatment option will also lead to a proliferation of potential uses for suffering patients.
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