FDA Approves Marketing Of Plant-Derived Marijuana Medicine

DISTRICT OF COLUMBIA:  Regulators at the US Food and Drug Administration on Monday granted market approval to Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD) for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

The proprietary extract formulation – developed by the British biotechnology firm GW Pharmaceuticals – had demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials. It is the fourth marijuana-based medicine to receive US FDA approval – joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros). However, Epidiolex is the first FDA-approved medicine containing plant-derived, non-synthetic cannabinoids.

Commenting on the agency’s decision, NORML Deputy Director Paul Armentano said: “We anticipate that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant. Nonetheless, these alternatives should not be regulated as options to replace the use and regulation of herbal cannabis – a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 30 states.”

Federal agencies have 90 days to determine the scheduling of Epidiolex under the US Controlled Substances Act. According to the New York Times, analysts expect Epidiolex to cost patients between $2,500 and $5,000 a month.

Despite the FDA’s approval of Epidiolex, the agency acknowledged in a statement that the cannabidinoid CBD still remains classified at this time as a schedule I controlled substance, and that the agency is “prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.” FDA Commissioner Scott Gottlieb further added: “This is the approval of one specific CBD medication for a specific use. … [T]his is not an approval of marijuana or all of its components.”


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org.

Study: CBD Extracts Significantly Reduced Seizure Frequency In Children With Refractory Epilepsy

ISRAEL: The adjunctive use of CBD extracts is safe and effective in adolescent patients with refractory epilepsy, according to clinical data published online ahead of print in the journal Brain & Development.

Israeli researchers assessed the sustained daily use of extracted CBD oils in a cohort of young patients with treatment resistant epilepsy.

Thirty-five percent of participants experienced a reduction in mean monthly seizure frequency of 75 percent or greater following CBD treatment. Forty-one percent of patients either partially or completely tapered their use of anti-epileptic drugs during the study period due to improvements in their condition. Patients who were younger than ten years of age at treatment onset experienced higher improvement rates compared to older subjects. The most commonly reported adverse side-effect of CBD treatment was somnolence, which was reported in 14 percent of patients.

Authors concluded, “In concordance with recent encouraging evidence, this open-label study using parental report, showed that CBD- enriched cannabis extract appears to have potential anti-seizure effect as an add- on treatment in pediatric patients with refractory epilepsy, with a favorable safety profile.”

The findings are similar to those of other recent trials reporting that the use of CBD extracts reduces seizure frequency and improves other symptoms of epilepsy. Regulators at the US Food and Drug Administration are anticipated to grant market approval this summer to a proprietary formulation of CBD oil, known as Epidiolex, for the treatment of Dravet syndrome and Lennox-Gastaut syndrome, two types of severe pediatric epilepsy.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Efficacy of CBD-enriched medical cannabis for treatment of refractory epilepsy in children and adolescents – An observational, longitudinal study,” appears in Brain & Development.

NY State To Hold Clinical Trials For Marijuana

NEW YORK: New York State is partnering with a British company to hold clinical trials for marijuana-based medication for children who have seizures that are resistant to their medicine.

An agreement was signed Sunday between Gov. Andrew Cuomo’s administration and GW Pharmaceuticals. The state Health Department and the company will develop the framework for a clinical trial for a marijuana-based drug for people under the age of 18.

It will involve Epidiolex, an investigational medication that uses cannabidiol, a marijuana extract that doesn’t get users high. It could help children with rare forms of epilepsy such as Dravet and Lennox-Gastaut syndromes.