Cannabis-Derived Prescription Medications
WRITTEN BY MICHAEL EKE AND DR. SWATHIClinical research has shown that there are many medical uses of cannabis-based formulations. The U.S. Drug Enforcement Administration (DEA) classifies cannabis as a Schedule I drug, asserting that it has no currently recognized medicinal use and a significant potential for misuse, which, in the past, has prevented rigorous research studies. That being said, unbeknown to most, there are a few cannabis-derived products that have been FDA approved or in process to be approved soon.
Nabilone (Cesamet) was FDA approved in 1985 for two indications: chemotherapy-induced nausea and vomiting (CINV) and HIV-related wasting syndrome. The DEA has listed it as a Schedule II substance, meaning that it is a prescription medication with a high level of medical oversight needed before it can be prescribed. It is a synthetic analogue of isolated tetrahydrocannabinol (THC), meaning that it is similar to THC, but not exactly the same.
Nausea and vomiting are among the most frequent side effects of chemotherapy and are the ones that cancer patients fear the most. The medical diagnosis for this is called chemotherapy-induced nausea and vomiting (CINV). As a result of the symptoms, some patients may decide to quit their therapy, endangering the course of their treatment. Some of the most prevalent side effects of cancer and cancer therapy can be relieved by medical cannabis. Along with CINV, many individuals also have symptoms including loss of appetite, excruciating pain, and others. As a result, cannabinoids can treat a variety of symptoms and enhance the quality of life for individuals who are affected. IIt is important to take nabilone as written in the instructions. Nabilone is also FDA approved for HIV-related wasting syndrome, aimed to increase appetite and bolster the immune system.
Believe it or not, dronabinol (Marinol) was approved in the same year for CINV. It is thought of as the less potent sibling of nabilone. It is a synthetic version of THC, so it has been created in the lab, rather than isolated from the cannabis plant. It is classified as Schedule III, meaning the DEA denotes it as potentially less addictive than nabilone.
In 2018, Epidiolex was FDA approved. It is indicated for a select number of pediatric seizure conditions, specifically Lennox Gastaut Syndrome and Dravet Syndrome, often shortened to LGS and DS, respectively. Greenwich Biosciences, recently acquired by Jazz Pharma, has a cultivation greenhouses in which the active cannabinoid involved–in this case, cannabidiol (CBD)–is grown and then isolated for products. Notably, this is the first cannabis plant-derived medication and first CBD-based formulation that was FDA approved in the US market.
Looking at both CBD and THC as a power is becoming increasingly of interest as these medications are used more often. Different ratios of CBD and THC can be used in pharmaceutical products to achieve various therapeutic effects.
A 1:1 cannabis ratio refers to the same amount of THC and CBD in a product. In equal parts, research suggests that THC and CBD are considered the perfect pair when it comes to treating medical conditions (opposed to getting “high”). The 1:1 CBD:THC formulation, in an oromucosal spray, called Sativex, is found widely available in many countries; it is approved for medical use in the management of muscle spasticity in Multiple Sclerosis (MS). It is currently undergoing clinical trials in the United States, en route to be FDA approved for use here too.
Now you know that there are a number of FDA approved products that are cannabis-derived or cannabis-inspired. To learn more information about cannabinoids could be a part of your wellness journey on our blog or CBD 101 page.
Sawtelle L, Holle LM. Use of Cannabis and Cannabinoids in Patients With Cancer. Ann Pharmacother. 2021;55(7):870-890. doi:10.1177/1060028020965224
Abu-Sawwa R, Scutt B, Park Y. Emerging Use of Epidiolex (Cannabidiol) in Epilepsy. J Pediatr Pharmacol Ther. 2020;25(6):485-499. doi:10.5863/1551-6776-25.6.485
Sekar K, Pack A. Epidiolex as adjunct therapy for treatment of refractory epilepsy: a comprehensive review with a focus on adverse effects. F1000Res. 2019;8:F1000 Faculty Rev-234. Published 2019 Feb 28. doi:10.12688/f1000research.16515.1
Pini LA, Guerzoni S, Cainazzo MM, et al. Nabilone for the treatment of medication overuse headache: results of a preliminary double-blind, active-controlled, randomized trial. J Headache Pain. 2012;13(8):677-684. doi:10.1007/s10194-012-0490-1
Pennypacker SD, Cunnane K, Cash MC, Romero-Sandoval EA. Potency and Therapeutic THC and CBD Ratios: U.S. Cannabis Markets Overshoot. Front Pharmacol. 2022;13:921493. Published 2022 Jun 6. doi:10.3389/fphar.2022.921493
Badowski ME, Yanful PK. Dronabinol oral solution in the management of anorexia and weight loss in AIDS and cancer. Ther Clin Risk Manag. 2018;14:643-651. Published 2018 Apr 6. doi:10.2147/TCRM.S126849
Bajtel Á, Kiss T, Tóth B, Kiss S, Hegyi P, Vörhendi N, Csupor-Löffler B, Gede N, Hohmann J, Csupor D. The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials. Pharmaceuticals. 2022; 15(1):100. https://doi.org/10.3390/ph15010100
This article was edited by Dr. Swathi and was written by Element Apothec Scientific Communications Intern, Michael Eke. He is a Doctor of Pharmacy (PharmD) candidate at Texas Southern University in Houston, Texas.