AXIM is actively involved in the research and development of innovative pharmaceutical delivery systems and cannabinoid-based APIs (active pharmaceutical ingredients) for treatment of conditions such as nausea in chemotherapy and AIDS patients, restless leg syndrome (RLS), and spasticity and pain associated with multiple sclerosis(MS).
The first program the company is focused on is MedChew™ with Dronabinol, which will undergo a bioequivalence study, comparing it to FDA-approved Marinol®. Marinol® was first introduced to the market in 1985 as a treatment for nausea and vomiting in chemotherapy patients. It is made with the API dronabinol, which is a synthetic form of the commonly known cannabinoid tetrahydrocannabinol or THC. AXIM has currently formulated its first batch of study drug and will perform a study on the release of the API through AXIM’s proprietary chewing gum delivery system. If bioequivalence is found between AXIM’s product and the product Marinol®, AXIM will seek FDA approval to release the gum under an extended IND.
Additional clinical development programs that AXIM is targeting in the short and mid-term include: MedChew™ RL which will undergo clinical trials as a potential treatment for Restless Leg Syndrome (RLS), MedChew™ Rx which will target treatment of pain and spasticity associate with Multiple Sclerosis, and CanChew™ Rx which aims to treat drug-induced psychosis. These were selected due to the shorter timeline and overall ability to bring the drugs to the market. The research protocols are conducted in strict adherence to the FDA/ EMA guidelines with the best chance to make it to market within 24-48 months.
These programs will utilize AXIX’s patented controlled-release, functional chewing gum delivery system which not only provides its proprietary API’s but also adds fundamentally unique additional benefits via the act of mastication. AXIM’s team of researchers is the first to realize the beneficial, neuroprotective benefits of the act of mastication, which added to its desire to develop the delivery system.
Additionally, AXIM has developed a unique extraction and freeze-drying technology for production of molecularly/genetically controlled—therefore extremely pure—pharma-grade cannabinoids extracted from industrial hemp that meet cGMP standards by the European Medical Association (EMA).
AXIM’s strategy for 2019-2021 was built to position the Company as one of the world leaders in the clinical development of novel cannabinoid-based medicines which AXIM hopes to accomplish in the short and midterms.