Medical Cannabis-Based Gum Moves into Production for Clinical Trials

medicalmarijuana May 9, 2017 Comments Off on Medical Cannabis-Based Gum Moves into Production for Clinical Trials
Medical Cannabis-Based Gum Moves into Production for Clinical Trials

As of May 2, 2017, one of the world leaders in cannabinoid research and development declared their product development partner, Quay Pharmaceuticals Ltd., also known as Quay Pharma, acquired a license from the British Home Office to continue research related to AXIM’s MedChew Rx® line of pharmaceutical chewing gum. This particular license allows the British-based pharmaceutical company to work with controlled drugs in order to continue with the development process of the product.

Currently, MedChew RX® is made with 5 mg of cannabidiol (CBD) as well as an equivalent dosage of tetrahydrocannabinol (THC). When the drug does hit the market, it’ll be used to treat pain and spasms in patients who have multiple sclerosis (MS). This particular condition is a degenerative disease that affects the central nervous system and disrupts how the brain and body communicate with one another. Current research published by the National Organization for the Reform of Marijuana Laws (NORML) indicates cannabis is effective at relieving pain and muscle spasticity in MS patients. A few of the studies propose cannabis may slow the advancement of the disease.

The research firm, GlobalData, estimated the value of the MS treatment market will rise to $20 million by the year 2024. The increased rate shows products used to treat MS will continue to draw in revenue. Additionally, the diagnosis rates for those with MS is projected to increase in the US as well as Germany, France, Italy, US, UK, Japan, China, Canada, India and Spain. The National Multiple Sclerosis Society already estimates that over 2.3 million individuals around the world have MS. The rise in the market value as well as the number of people with MS means a product like MedChew RX® is more than likely to going to have great success in the aforementioned regions of the world.

AXIM Biotech, a pharmaceutical company that obtains cannabinoid strains from the Dutch Government’s Office of Medicinal Cannabis, will work with its partners to develop and produce the MedChew family of chewing gums. AXIM Biotech will work with their partners to secure strains of marijuana to extract the THC and CBD. They’ll be working with Bedrocan BV, which is a growing facility located in the Netherlands. After they’ve secured the strains, they will be able to extract and purify them, so they’re converted into a pharmaceutical-grade cannabinoid. For this process, they’ll be working with Syncom BV, which is a company who has unique extraction and purification methods for pharmaceutical-grade cannabinoids. Syncom BV has already applied for patents for their methods. Once all of this process is completed, the chewing gum will need to undergo clinical trials to determine the safety and effectiveness of the chewing gum.

Xendo B.V. will have the responsibility of handling regulatory affairs while the international clinical research association in the Netherlands, QSP, will be in charge of managing the clinical strategy and trials. It’s vital for the organizations to mind all regulations enforced by the U.S.’s Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The primary focus of developing the gum is formulating the product, so it’s absorbed orally in a manner that promotes the best pharmaceutical outcome for patients. The chief technology officer at AXIM stated the project is on track. They will need to make various prototypes to determine which layer the active ingredients in the gum should be in. This helps to make the most effective and safest product.

Once the pharmaceutical development company achieves stability with the product, the clinical trials will begin with Phase 2A scheduled at the Free University in Amsterdam. The clinical trials will move into Phase 3 at the Vrije Universiteit Amsterdam, which should happen as early as 2018. The Phase 3 clinical trials are for both the US and the UK.

AXIM states the gum is a less expensive alternative when compared to many other medications for MS. AXIM Biotechnologies anticipates the gum becoming a viable alternative to Sativex, an under-the-tongue spray consisting of marijuana that’s currently used in 27 countries around the world. However, it’s still prohibited in the US because of federal regulations that dictate which medical marijuana products are on the market. While gum itself has benefits, so does its delivery system. For instance, chewing promotes neurogensis and stimulates the cardiovascular system. Moreover, it promotes better oral health. Chewing gum has short-term effects such as arousal and an improvement in cognition. It reduces stresses and improves a person’s breath. One of the long-term benefits is a reduction in the loss of cognition that occurs due to age. It also reduces the prevalence of dry mouth because it stimulates the production of saliva.

AXIM is a biotechnology company that conducts research, develops and produces nutraceutical and pharmaceutical products as well as cosmetics. AXIM Biotech was partially responsible for developing extraction and purification methods for pharmaceutical-grade cannabinoids with 99.9 percent purity. We’re wondering if their cannabis-based chewing gum is just the start of AXIM’s work with cannabinoids.

Comments are closed.