April 17, 2018 Food and Drug Administration staff has favorably reviewed GW Pharmaceuticals’ Epidiolex data in a document sent to an advisory committee that will soon decide whether to approve the “almost-pure-CBD” plant extract as a treatment for Dravet syndrome and Lennox-Gastaut syndrome.
In hospital-based clinical trials tracking more than 400 children with these severe forms of epilepsy, Epidiolex reduced the frequency and severity of seizures by about 40%. Adverse events in the liver were detected in 14% of Epidiolex patients versus 3% of patients given placebo. But the FDA document states, reassuringly:
“The observed risk can be appropriately managed with inclusion of relevant language in labeling, education of prescribers regarding the risk of transaminase elevation and need for monitoring of liver enzyme levels, and further characterization of the risk in the post-market setting.”
It is exactly 20 years since Drs. Geoffrey Guy and Brian Whittle got approved by the Home Office to grow Cannabis in the UK to develop plant-extract medicines.
Bonus track: https://fredgardner.bandcamp.com/track/grinspoon-and-guy