U.S. laws and regulations concerning CBD are determined at the state level. Currently, 33 states have legalized CBD use for medical purposes, and 10 states (Alaska, California, Colorado, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont, and Washington) and the District of Columbia have legalized marijuana for recreational use. In states such as New York, Minnesota, and Connecticut, pharmacists are required to dispense the products in authorized dispensaries. Marijuana-derived CBD oil is still considered illegal under the Controlled Substances Act in accordance with the DEA’s classification of marijuana as a Schedule I substance. 2
As noted earlier, Epidiolex (CBD) is an FDA-approved oral solution for treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome. The cost of Epidiolex is approximately $2,708 per month. It is supplied as 100 mL of solution containing CBD 100 mg/mL. For both indications, the initial starting dosage is 2.5 mg/kg orally twice daily for 1 week. The dosage may be titrated weekly in increments of 2.5 mg/kg twice daily to a maintenance dosage of 5 mg/kg twice daily. The maximum dosage is 10 mg/kg twice daily or 20 mg/kg/day. Gradual tapering is recommended when Epidiolex is discontinued. 3
Selecting a Non–FDA-Approved CBD Product
Clinical findings on the use of CBD oil in Parkinson’s disease (PD) remain unclear. Past studies have evaluated CBD’s efficacy in minimizing nonmotor symptoms of PD, such as cognitive deficits, sleep disturbances, psychosis, depression, and anxiety. 10 The neuroprotective properties of CBD have been studied in animals with PD, with results indicating that CBD appears to reduce psychotic symptoms. 11 Although patients with PD have reported fewer sleep disturbances as well as improvements in quality of life, treatment in humans requires further investigation on a larger scale, with longer durations and more standardized dosing. 12 Most studies have used combinations of CBD and THC extracts, including nabilone, a synthetic CB1 receptor agonist. CBD dosages of 150 mg/day for 4 weeks and titrated by 140 mg/week were found to be safe and well tolerated and did not worsen motor function. 10
Pharmacists must educate patients about how to select an appropriate non–FDA-approved CBD product. These products are not tested for safety, efficacy, or quality. 4 The main concerns in picking a non–FDA-approved CBD product are that it may contain harmful chemicals and may not accurately list the correct amounts of CBD and THC it contains. These products could contain harmful contaminants (e.g., pesticides, heavy metals) or have high levels of THC, which would result in a positive urine drug test. 5 The patient should be advised to obtain CBD products from a medical dispensary because these products are regulated. The patient should also consider ordering products from states where CBD is legal because more testing is done in those states. When selecting a product, the patient should check the label to see if it lists the amount of CBD in each dose. 5,6 The manufacturer should provide a Certificate of Analysis, which shows an independent laboratory’s assessment of the product’s potency and the presence of contaminants. 5 When assessing quality, the patient should look for the Hemp Authority seal, which means that the product is legal and the manufacturer is adhering to quality standards. 7
Other interactions to be aware of are presented in TABLE 1.
While CBD’s mechanisms are not fully understood, researchers are looking at how it influences cannabinoid receptors in the brain known as CB1 and CB2. CBD itself does not bind to CB1 and CB2 receptors, but instead causes endocannabinoid compounds made by the body to do so, leading pharmaceutical researchers down a new path toward CBD-based treatments.
The CB2 receptor is of special interest to drug developers, as it is associated with anti-inflammatory effects. By activating this receptor directly with a potent CBD derivative, researchers can take aim at treating chronic inflammatory diseases, including lupus, cystic fibrosis and multiple sclerosis.
From skincare to snacks, CBD can be found in a vast array of products. Although many consumers tout the benefits of CBD, scientists argue that the health claims are unsubstantiated. In fact, only one CBD-based drug, which helps control seizures in children, is approved for use by the U.S. Food and Drug Administration (FDA), writes Senior Editor Britt E. Erickson.
In addition, companies are working to enhance the aqueous solubility of CBD, meaning that it can be more readily absorbed by the body when taken orally. By doing so, scientists hope to create drugs that are up to 50 times more potent than CBD, which could help with nerve damage, neurodegenerative diseases and even opiate abuse.
Cannabidiol (CBD) is an increasingly popular wellness trend. The compound, which occurs naturally in cannabis plants, is added to many products that claim to reduce anxiety, alleviate pain and more, without the intoxication of its cousin tetrahydrocannabinol (THC).
While CBD products are largely unregulated and unproven, companies are working to create CBD-like molecules to develop pharmaceutical therapies. Their progress is reported in Chemical & Engineering News, the weekly newsmagazine of the American Chemical Society.
Most of these potential drugs are still in the early stages of development, and researchers caution that clinical trials might not pan out. However, the amount of interest and investment in developing these drugs could signal a new era of pharmaceutical innovation.