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cbd oil epilepsy study

An Israeli study using a product that had 20 parts of CBD to 1 part of THC was performed in an open-label format for children up to age 18 years with hard to control epilepsy. A significant number of people reported seizure reduction with 7% stating seizures worsened.

On June 25, 2018, the U.S. Food & Drug Administration (FDA) approved EPIDIOLEX ® (cannabidiol, CBD) oral solution for the treatment of seizures associated with two epilepsy syndromes – Lennox-Gastaut syndrome and Dravet syndrome – in people two years of age or older. Epidiolex represents a new medication option for children with these types of epilepsy. It is also the first ever FDA approved medication to treat seizures in Dravet syndrome.

NEJM May 2017

Are there ongoing CBD clinical trials?

Over half of U.S. states have laws allowing cannabis to be recommended and dispensed to people for medical reasons. The 2018 Farm Bill does not change existing laws surrounding state medical cannabis programs. Individuals who purchase treatments through a medical dispensary and via a recommendation from their physician are still required to follow the regulations set forth including registration, renewal of medical cards, and other requirements decided by each state.

Results from 214 people who received Epidiolex (99% CBD) in an open-label study (without a placebo control) and who completed 12 weeks or more on the drug were published in 2015 in Lancet Neurology.

In June 2018, the FDA approved Epidiolex allowing medical providers to prescribe this medication for Lennox-Gastaut and Dravet syndromes, similar to how they are able to prescribe other seizure medications. In late September 2018, the DEA rescheduled Epidiolex to Schedule V and all states and the District of Columbia have created pathways so that it can be brought to market for consumers. Read an FAQ to learn more.

NEJM May 2018

The recommended guidelines are still only draft and the consultation closes on 16 September. So there is still time for you to have your say and let them know what you think. Professor Sander will be doing the same. All comments received will be considered by NICE and final guidance is likely to be published in November 2019.

Dosing data for adults is currently very limited, although more information is expected shortly.

Guidance around prescribing cannabis-based products

Interim guidance from the ABN states that there is only published evidence for the use of medicial cannabis in Dravet syndrome and Lennox-Gastaut syndrome. Prescriptions should only be for cannabidiol.

The BPNA guidance states that non-licensed medicinal cannabis should only be considered for children who:

The BPNA states that the current best evidence for medicinal cannabis is CBD, a highly purified liquid, which has been licensed in the US by the Food and Drug Administration and is currently going through the application process for a licence from the European Medicines Agency.