Approved indications for cannabis-based preparations

Abstract

In traditional medicine, cannabis-based preparations have been used for a thousand of years for treatment of various diseases. The clinical use of cannabis-based preparations is limited due to legal and ethical reasons, and therefore there is a lack of data for the therapeutic potential of cannabinoids. By searching the FDA site, we identified three approved cannabis-based medicines for treatment of anorexia, nausea and vomiting caused by chemotherapy and two particularly severe forms of child epilepsy (Lennox-Gastaut and Dravet's syndrome). By searching the EMA site, we identify only one cannabis-based medicine authorized for use in the European Union – Epidyolex. But, EMA recognized possible positive therapeutic outcome of three cannabinoids (cannabidiol, cannabinol-9-carboxylic acid (resunab and lenabasum) and cannabidivarin) for which by the European Commission was granted status "Orphan designation" for 12 different indications: treatment of: tuberous sclerosis, West syndrome, Drave's syndrome, Lennox-Gastaut's syndrome, graft-versus-host disease, perinatal asphyxia, glioma, systemic sclerosis, cystic fibrosis, dermatomyositis, Rett syndrome and fragile X syndrome. The adverse effects of cannabis preparations are primarily due to THC, which has psychotropic effects and used in higher doses can cause certain central nervous system (CNS) disorders. Chronic use of THC may cause an excessive hyperemetic syndrome, which is always weaker than the side effects that cause hemotherapy. For many patients who do not respond adequate to conventional therapy, cannabis preparations are the only possible option evenif cannabinoids are less potent than conventional therapy.