An upcoming clinical trial by Medical Marijuana, Inc. investment company AXIM® Biotechnologies has been included in the U.S. Government’s website clinicaltrials.gov, placing it among the medical community’s most important research work.
AXIM®’s Phase I clinical trial is intended to determine the bioavailability of the synthetic cannabinoid dronabinol in two different formulations. This clinical study will pave the scientific foundation for AXIM and its controlled-substance API partner to co-develop a dronabinol-based, controlled-release chewing gum product.
AXIM® will create a functional 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 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.
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 first pass metabolism in the liver enough that AXIM® Biotechnologies believes their new formulation will improve efficacy while simultaneously reducing side effects for patients who utilize this new delivery method.
Marinol may be prescribed by doctors 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.
Listed among the clinical trials being performed by major pharmaceutical companies around the world, the inclusion of AXIM®’s work on cannabinoids alongside other clinical trials is an important step towards the normalization of cannabinoids like THC and CBD as therapeutic compounds.
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).
In 1997, U.S. Department of Health and Human Services (HHS), through NIH, established a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug applications to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions. NIH and the Food and Drug Administration (FDA) worked together to develop the site, which was made available to the public in February 2000.
With the primary purpose of improving access of the public to clinical trials where individuals with serious diseases and conditions might find experimental treatments, this law required information about federally and privately funded clinical trials; the purpose of each experimental drug; subject eligibility criteria to participate in the clinical trial; the location of clinical trial sites being used for a study; and a point of contact for patients interested in enrolling in the trial. The site lists nearly 250,000 clinical studies from the U.S. and over 200 countries internationally.
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