The first cannabis drug to be approved by the FDA is going to be revived in the form of chewing gum. AXIM® Biotechnologies Inc. (AXIM® Biotech) (OTCQB: AXIM) has entered into a Term Sheet Agreement with a U.S.-based API company to develop the bioequivalent of Marinol in a gum form.
Marinol, a dronabinol approved by the FDA in 1985 for the treatment of nausea and vomiting caused by chemotherapy treatments and AIDS, has historically been delivered through a fixed-dose gel capsule, taken by the mouth. Nausea and vomiting are common side effects of chemotherapy, and often lead to dehydration and difficulties obtaining nutrition the body needs. The American Cancer Society says that about 1 in 3 chemotherapy patients experience anticipatory nausea.
While Marinol has proven effective for managing nausea and vomiting, the method of administration often causes adverse side effects that commonly force patients to stop using the drug after one round. As a gel capsule, 90% of the dronabinol is metabolized into the psychoactive compound 11-OH-Tetrahydrocannabinol (THC) when it passes through the liver, inducing extreme impaired thinking and reactions. When delivered as a chewing gum, however, the dronabinol is absorbed from the mouth and directly enters the bloodstream, skipping the liver.
“This is a substantial step forward to improving the current product offerings on the market for patients who are suffering these types of symptoms,” said George E. Anastassov, MD, DDS, MBA and Chief Executive Officer of AXIM Biotech, in a press release. “Currently there is a 45% drop out rate of patients who take Marinol, we are hopeful that our innovative chewing gum delivery method will lead to decreased side effects and allow for a better quality of life for these patients.”
The API company partnering with AXIM will provide the dronabinol used in the research and development of the Marinol bioequivalent chewing gum. Once pre-clinical research and a bioequivalency study are completed, AXIM and the API company will seek FDA approval to bring the chewing gum to the U.S. market.
Anastassov expects that the FDA will give AXIM’s form of the dronabinol drug the same schedule 3 classification given to Marinol three decades ago. If it does, it can be produced overseas, where better supplies of cannabis are available, and then imported. A schedule 2 classification would call for the drug to be produced domestically.
Doctors wrote 273,000 prescriptions for dronabinol in 2015, up from 243,000 in 2011. The $160 million market worldwide for Marinol could change dramatically in the coming year. Anastassov believes the Marinol market will grow to $300 million-plus once the improved form from AXIM is approved. He told Forbes earlier this week that the path to registration with the FDA and the dronabinol gum’s introduction into market could take just 12 months.