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AXIM Biotech Announces Successful Completion of Pre-IND Meeting with FDA on Comparable Product to Marinol; Green Light from FDA for IND Submission
AXIM Biotech Announces Successful Completion of Pre-IND Meeting with FDA on Comparable Product to Marinol; Green Light from FDA for IND Submission.
About this update from Axim Biotechnologies, Inc.
[{"type":"text","content":"\n\n NEW YORK, Dec. 12, 2017 (GLOBE NEWSWIRE) -- AXIM® Biotechnologies, Inc. (OTC:AXIM), a world leader in cannabinoid research and development, announced today that it has successfully completed a pre-investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for a dronabinol-based functional, controlled-release chewing gum product it’s developing to help treat patients with chemotherapy-induced nausea and vomiting and HIV/AIDS patients experiencing appetite and weight loss. AXIM will now begin preparing its IND filing to the FDA for this new chewing gum product, referencing Marinol®, one of the FDA-approved, dronabinol-based drugs available in the U.S.\n “We are very pleased with the outcome of our pre-IND meeting with the guidance of the FDA, which enabled us now to submit the protocol for clinical development of this dronabinol-based chewing gum that we believe could truly be a breakthrough utilizing Oral Mucosal absorption and those who suffered from the side effects of Marinol,” said George E. Anastassov, MD, DDS, MBA and Chief Executive Officer of AXIM Biotech. “After getting the green light from the FDA, our team will now be working diligently towards the submission of our IND, another major milestone for AXIM Biotech.” In its current form, Marinol is delivered through a gel capsule where 90% of the dronabinol is metabolized into 11-OH-THC due to the first-pass (liver) metabolism. This may cause significant undesirable side effects for patients including impaired thinking and other adverse reactions. AXIM’s patented controlled-release chewing gum will be designed to largely bypass the first-pass metabolism in the liver with the goal of decreasing side effects for patients. About AXIM®  AXIM® Biotechnologies, Inc. (AXIM) focuses on the research, development and production of cannabis-based pharmaceutical, nutraceutical and cosmetic products. Our flagship products include CanChew+®, a CBD-based controlled release chewing gum, CanChew+ 50®, containing 50 mg of CBD undergoing clinical trials in patients with IBS and MedChew Rx®, a combination CBD/THC gum that will undergo clinical trials for the treatment of pain and spasticity associated with mul...