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 and vomiting with chemotherapy and lack of appetite and cachexia in HIV/AIDS patients, pain and spasticity in restless leg syndrome (RLS), and spasticity and pain associated with multiple sclerosis(MS).
The first program the company is to conduct is MedChew™ with Dronabinol, which will undergo a bioequivalence study comparing it to FDA-approved dronabinol. Dronabinol was first introduced to the market in 1985 as a treatment for nausea and vomiting induced by chemotherapy. Dronabinol is a synthetic form of the commonly known cannabinoid tetrahydrocannabinol or THC. AXIM has currently formulated the drug and will perform a study on the release profile 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 for the pharmaceutical bioequivalent.
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 designed in strict adherence to the FDA/ EMA guidelines providing the best chance for a regulatory approval and accelerated market entry within 24-48 months.
These programs will utilize AXIM’s patented controlled-release, functional chewing gum delivery systems, which not only predictably provide its proprietary API’s but also adds fundamentally unique additional benefits via the physiological act of mastication.
Additionally, AXIM has developed a unique extraction and purification technology for production of extremely pure—pharma-grade cannabinoids which meet the strictest cGMP standards.
AXIM’s strategy for 2019-2021 is 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.