Category Archives: Epidiolex (Cannabidiol)

‘Off-Label’ Use of Epidiolex (Cannabidiol; CBD) and Tilray 2:100 for Pain?

Feature Image of Epidiolex (cannabidiol; CBD) bottles sourced from:

https://www.bloomberg.com/news/photo-essays/2018-10-31/gw-pharmaceuticals-s-epidiolex-cannabis-based-epilepsy-drug

Dear Pain Matters readers,

Epidiolex (Cannabidiol; CBD)

Overview

An oral solution called Epidiolex (cannabidiol; CBD) was approved on 25 June 2018 by the US Food and Drug Administration (FDA).  Made by GW Pharmaceuticals, Epidiolex may be used for the treatment of epileptic seizures in patients with Lennox-Gastaut syndrome and Dravet syndrome aged 2 and above.

Epidiolex is the first FDA-approved drug that is based on a molecule (i.e. CBD) derived from marijuana (in this instance, CBD-rich cannabis).  Contrary to tetrahydrocannabinol (THC) that may lead to a ‘high’, the CBD molecule does not exert psychoactive effects.

For more information about CBD and pain, please visit my blog post called:

Cannabidiol (CBD) – ‘Cannabis With the Fun Bit Taken Out’ – For Severe Chronic Pain

Possible ‘Off-Label’ Use of Epidiolex (Cannabidiol; CBD) for Pain

Given that:

  • Cannabidiol (CBD) may offer pain relief; and
  • Epidiolex virtually is CBD,

‘off-label’ use of Epidiolex for pain may be warranted (Anson, 2018; Urits et al, 2019).

Thus, while specifically approved for the treatment of certain epileptic conditions, ‘off-label’ prescription by doctors for Epidiolex for pain may be possible.

Tilray 2:100

Tilray 2:100 (that is comparable to Epidiolex) is now available in Canada for patients with epilepsy.  Tilray 2:100 offers a target concentration of 100 mg/ml of CBD and 2 mg/ml of THC (Henriques, 2019; Tilray, 2018).

Similar to Epidiolex, ‘off-label’ prescription by doctors for Tilray 2:100 for pain may be warranted.

Summary

You may ask yourself,

‘Why would anyone request an ‘off-label’ prescription for Epidiolex or Tilray 2:100 when one could simply buy CBD for pain online (where legal)?’

According to Kyle Varner, MD, Internal Medicine Specialist in Washington:

‘CBD oil has tremendous therapeutic potential.  Epidiolex is just CBD— but sold at a price tag of over $30,000 per year’ (Tapp, 2019).

The answer is that many CBD products sold online are mislabeled and unregulated.  This may lead to ineffective treatments and/or side effects (Bonn-Miller et al, 2017).

As such, Epidiolex and Tilray 2:100 may be prescribed ‘off-label’ for pain in the US and Canada, respectively (in addition to, or instead of, CBD).

This is great news!  Now there are more treatment options available for pain!

Please forward to anyone who may benefit from this blog post.

Sabina Walker

Blogger, Pain Matters (in WordPress)

REFERENCES

Epidiolex

(1) Urits et al. An Update of Current Cannabis-Based Pharmaceuticals in Pain Medicine. Pain Ther (5 Feb 2019).

doi: 10.1007/s40122-019-0114-4.

https://www.ncbi.nlm.nih.gov/pubmed/30721403

(2) Anson, Pat. FDA Approves First Marijuana-Based Prescription Drug. Pain News Network (25 June 2018).

https://www.painnewsnetwork.org/stories/2018/6/25/fda-approves-first-marijuana-based-prescription-drug

(3) van der Walt, Eddie & Dawson, Rob.America’s First Cannabis-Based Medicine Is Made in England. Bloomberg (31 

https://www.bloomberg.com/news/photo-essays/2018-10-31/gw-pharmaceuticals-s-epidiolex-cannabis-based-epilepsy-drug

(4) FDA. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. FDA (25 June 2018).

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611046.htm

(5) Tapp, Fiona. Businesses envision a boom in CBD, the non-intoxicating oil from hemp. Boston Globe (24 Jan 2019).

https://www.bostonglobe.com/news/marijuana/2019/01/24/businesses-envision-boom-cbd-non-intoxicating-oil-from-hemp/TQhuB0EErYvrpNxpTXTXxJ/story.html

Tilray 2:100

(1A) Henriques, Carolina. Tilray Launches New High-CBD Cannabis Oil for Seizure Treatment in Canada. Dravet Syndrome News (29 May 2019).

https://dravetsyndromenews.com/2018/05/29/tilray-launches-new-high-cbd-cannabis-oil-seizure-treatment-canada/

(1B) Tilray Introduces New High-CBD Extract. Tilray (06/19/2018).

https://www.tilray.ca/en/blog/post/tilray-introduces-new-high-cbd-extract/

Labelling Accuracy of Cannabidiol Available Online

(1A) University of Pennsylvania School of Medicine. Nearly 70 percent of cannabidiol extracts sold online are mislabeled, study shows. Science Daily (7 Nov 2017).

https://www.sciencedaily.com/releases/2017/11/171107112244.htm

(1B) Royal Queen Seeds. The Recent Approval of Epidiolex and its Implications. 

https://www.royalqueenseeds.com/blog-the-recent-approval-of-epidiolex-and-its-implications-n1014

(1C) Bonn-Miller et al. Labeling Accuracy of Cannabidiol Extracts Sold Online. JAMA (2017); 318(17): 1708.

doi: 10.1001/jama.2017.11909

https://jamanetwork.com/journals/jama/fullarticle/2661569