Medicinal cannabis chewing gum in clinical phase
Nicotine gum is probably the most well-known medicinal application. But chewing gum containing medicinal cannabis is something new. So new that the first batch has not even been made yet. AXIM Biotechnologies developed the product and is waiting to start the first clinical trials in the Netherlands, Israel and Canada.
Earlier this month they uncorked the champagne bottles at both the American head office in New York and in the Netherlands. The company that is listed on the American stock market (AXIM U.S.: OTC) received a GMP certificate from the Dutch government to produce samples for clinical trials. This test medication may now be used worldwide as a research resource. This is a huge milestone for the company that has been trying to bring medicinal cannabis gum onto the market since 2007.
MedChew Rx, a type of gum produced by AXIM looks very promising. It contains 5 milligrams of CBD – a non-psychoactive component of cannabis – and 5 milligrams of THC – a psychoactive cannabinoid. The cannabis for this chewing gum is supplied by Bedrocan. The medication was developed to treat pain and spasms in Multiple Sclerosis (MS) patients. The Dutch VU University Medical Center in Amsterdam will carry out the clinical trials.
Motion sickness, pain, quitting smoking, dental decay and middle ear infections are all well-known or lesser-known medical conditions for which medicinal chewing gum is available. AXIM consciously chose chewing gum as a method of administration.
According to Lekhram Changoer, Chief Technology Officer, it is a socially accepted and user-friendly method. Much more so than smoking or inhaling cannabis. And does it work? Changoer: “Chewing has a considerable effect. Chewing activates your brain. Scientists at the Vrije Universiteit in Amsterdam have proven that the medication has a greater effect when chewed, especially for pain.”
More clinical trials
AXIM Biotechnologies will be carrying out more clinical research next year. QPS, a medication research company based in Groningen (Netherlands), will conduct a study on chewing gum with synthetic dronabinol (THC). This gum should, among other things, prevent nausea and vomiting (chemotherapy) or stimulate the appetite (anorexia, AIDS). The University of British Columbia in Canada will carry out clinical trials for treating drug-related psychoses with cannabis chewing gum. A double-blind, randomised, phase 2 study with 30 RLS patients will start in Israel next year.
Restless Leg Syndrome
AXIM Biotechnologies developed a chewing gum containing CBD to help patients suffering from Restless Leg Syndrome (RLS). RLS patients suffer from muscle spasms in their lower legs, knees and sometimes arms during the night. This leads to sleep disorders and the condition is also often accompanied by excruciating pain. The gum contains 1,000 milligrams of CBD and gabapentin, an anticonvulsant.
Just like a pill
According to Changoer, physicians have responded positively to this administration method: “It is not entirely new. They are already familiar with nicotine gum. Physicians don’t want their patients to smoke cannabis because it is unhealthy. Some physicians are also weary of inhaling. Not all patients can or want to use a vaporizer. Chewing gum is easy to take with you, just like a pill.”
The goal is to have the gum officially registered as medication. This way a physician can prescribe it and determine the dose. But clinical trials must first show that the product works.
Changoer: ”Preliminary studies paint a positive picture of the implementation of CBD and THC. Research will provide us with more insight into dosage. The approach is that the patient will calmly chew on one piece of gum for about twenty minutes. The absorption of the active chemicals will then take place via the mucous membranes in the cheek.” Changoer expects it will take at least another three years before the chewing gum will be available on the market.