AXIM® Biotechnologies, a major Medical Marijuana, Inc. investment company, has taken the first steps toward developing a chewing gum bioequivalent to Marinol, made using a synthetic version of THC or tetrahydrocannabinol.
This week, AXIM® Biotechnologies revealed that it entered into a Term Sheet Agreement with a U.S.-based Active Pharmaceutical Ingredient (API) production company. Through this agreement, AXIM® will create a functional dronabinol-based chewing gum similar to Marinol using the company’s intellectual property, including their patent on CBD-based controlled release chewing gum that was recently expanded to include all cannabinoids, including THC.
AXIM® will be creating their new drug using dronabinol, an isomer of THC that was originally used to make Marinol. First introduced in the U.S. market in 1985, Marinol remains the only FDA approved cannabis-based drug available in the U.S. Axim®’s dronabinol-based gum is intended as a design improvement over Marinol, addressing both safety and efficiency.
“AXIM has once again expanded its clinical research program in an impressive and important way that will greatly benefit this population of patients,” said Dr. Stuart Titus, PhD, CEO of Medical Marijuana, Inc. “With more than a third of patients discontinuing use of Marinol as prescribed due to adverse side effects, it is encouraging that AXIM® will research and attempt to bring to market an improved medication that may provide expanded therapeutics while allowing for a better quality of life for this patient population.”
Marinol may be prescribed for the treatment of cachexia (weight loss) in patients with AIDS and for the treatment of nausea and vomiting associated with cancer treatment. Marinol is typically reserved for patients who have failed to respond adequately to conventional antiemetic treatments. AXIM® will pursue these same indications in its clinical research on their chewing gum replacement. The total market size for Marinol and generic dronabinol products has reached $150 million for all indications.
Marinol is manufactured as a gelatin capsule containing synthetic delta-9-tetrahydrocannabinol (THC) in sesame oil. It is taken orally and is available in 2.5mg, 5mg and/or 10mg dosages. In its current capsule form, Marinol is metabolized into 11-OH- THC when it passes through the liver. This metabolite causes significant side effects for patients, including impaired thinking, lightheadedness, negative mood changes, and other adverse reactions.
AXIM’s patented controlled release chewing gum largely bypasses the first pass metabolism in the liver to the point where AXIM® Biotechnologies believes their new formulation will improve efficacy while simultaneously reducing side effects for patients who utilize this new delivery method.
This preliminary agreement between AXIM® Biotechnologies and its API company creates the necessary conditions for AXIM® to move forward with their pursuit of this improved delivery system for FDA approved dronabinol.
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