FDA Approves Epidiolex

August 31, 2018 3 288
FDA Approves Epidiolex

The US health regulatory body, the Food and Drug Administration, is notoriously lengthy in its deliberations on approving pharmaceutical drugs.  However on 25th June 2018, the FDA approved the first prescription drug made from plant-derived Cannabidiol (CBD), one of the active ingredients in marijuana.

The newly approved medication, Epidiolex, contains pharmaceutical grade CDB oil and has been found to reduce seizure activity in two rare forms of epilepsy (Dravet and Lennox-Gastaut syndromes) in largely paediatric patients, some as young as 2-years-old. Which helps to explain why Epidiolex comes as a strawberry-flavored syrup!  

This approval is significant for multiple reasons. It is the first time a plant based CBD only medicine has been approved by the FDA. In the broader context, FDA acceptance of a cannabis-derived medication will allow various jurisdictions to rethink their position on medicinal cannabis in general.

The implication for patients in New Zealand is unclear.  Often, if a drug is registered with the FDA in the US, it will (eventually) become recognized in New Zealand by Medsafe. This is good news for patients as it means the product is considered safe and easily prescribed by doctors. It can, however, also mean higher costs, as the effort spent to get the FDA registration of the drug needs to be recouped, and that is through higher prices to patients.

Importantly, New Zealand doctors can already prescribe medicinal marijuana in the form of products that contain Cannabidiol (CBD) only.  Most of these CBD Oil products come from Canada and are very similar to Epidiolex but they are not recognized by FDA or any regulator, as pharmaceutical products.

If Epidiolex is made available in New Zealand and recognized as a legitimate pharmaceutical product what does that mean for CBD oils currently being prescribed here? Will they no longer be permitted? If they are permitted, how will a more expensive drug that it essentially the same product, survive?  Stay tuned.

For more information about Epidiolex and medicinal cannabis trials for children with severe treatment-resistant epilepsy in Australia, see links online:

https://www.epilepsyqueensland.com.au/sites/www.epilepsyqueensland.com.au/files/Medicinal%20cannabis%20-%20Queensland%20clinical%20trials%20%283%29%20270716.pdf

https://www.medicinalcannabis.nsw.gov.au/clinical-trials/paediatric-epilepsy-trial

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