AXIM Biotech announced that they have obtained the necessary license requirements from the British Home Office to develop and produce their family of MedChew Rx® pharmaceutical chewing gum products.
MedChew Rx® is a first-of its kind pharmaceutical, functional chewing gum containing 5 mg of cannabidiol (CBD) and 5 mg of tetrahydrocannabinol (THC) for the treatment of multiple sclerosis (MS) and its associated symptoms.
MS is a chronic degenerative disease of the central nervous system that affects more than 2.3 million people worldwide, according to the National Multiple Sclerosis Society. As of now, there is no cure for MS, which commonly causes inflammation, pain, and spasticity. GlobalData projects the worldwide MS treatment market to reach $20 billion by 2024.
“We are excited to move forward the development of MedChew Rx® pharmaceutical chewing gum with our world-class research and product development partners,” said George E. Anastassov, MD, DDS, MBA and Chief Executive Officer of AXIM Biotech, in a statement. “For now we are focusing on the prototypes of MedChew chewing gums and ensuring our products comply with all FDA/EMA regulations. After achieving product stability, we will start efficacy Phase 2A clinical trials at the Free University in Amsterdam, and subsequently move into Phase 3 clinical trials in Vrije Universiteit Amsterdam, for the UK and USA. We anticipate to complete Phase 3 clinical trials in early 2018.”
AXIM Biotech obtains its cannabis materials from the Dutch Government’s Office of Medicinal Cannabis (OMC) and then with Quay Pharma, uses its proprietary processes to extract and purify the strains into pharmaceutical-grade cannabinoids and develop a 99.9% pure cannabinoid-containing chewing gum. Xendo B.V. is handling regulatory affairs and Quay Pharma will manage clinical strategy and trials.
“It is a very exciting development process we have embarked on with AXIM and we are delighted to be supporting them on their range of projects. The development of the MedChew RX® gum will be carefully formulated to ensure that the drugs are preferentially absorbed orally within a specific window of time to provide the best therapeutic outcome for the patients,” said Maireadh Pedersen, Chief Executive Officer of Quay Pharma.
Just last month, AXIM Biotech announced it had entered into a Term Sheet Agreement with a U.S.-based API company to revive the only FDA-approved dronabinol drug as a chewing gum.