Epidiolex: A New FDA Approved Epilepsy Medication

by Roxanna Orsini, PharmD Candidate Class of 2019,
University of Arizona

August 28, 2018

new-epilepsy-drug

Treatments are available that can successfully control seizures for most people with epilepsy. However, there’s a soon-to-be-released medication, recently approved by the FDA, called Epidiolex.

What is Epidiolex?

Epidiolex (cannabidiol) is a new FDA-approved epilepsy medication that is derived from Cannabis Sativa plant (marijuana). Cannabidiol (CBD) does not create feelings of euphoria or intoxication, the “high” that is often experienced with Cannabis, which comes mainly from the compound tetrahydrocannabinol (THC), which is also found in marijuana.

Which forms of epilepsy does Epidiolex treat?

The FDA approved Epidiolex for treatment of seizures associated with two rare and severe forms of epilepsy, in patients two (2) years and older.5

  • Lennox-Gastaut Syndrome
    • Begins in childhood and continues to adulthood with some changes in presentation with age.3
    • Often characterized by multiple types of seizures (particularly tonic and atonic) and an intellectual disability.
    • An EEG (electroencephalogram) can display a classic pattern of background slowing and spike-wave bursts with frequencies less than 2.5 per second. 2
    • Found in 2-5% of childhood epilepsies.2
  • Dravet Syndrome
    • Begins during the first year of life and is a lifelong disease.3
    • This is a rare genetic epileptic brain disease.
    • Infants will have normal development up until an increase in seizure frequency occurs after the first seizure which is often associated with a fever. 1
    • Most children develop some level of developmental disability.
    • Seizures can be triggered by various factors such as body temperature, emotional stress or excitement, and photosensitivity.1

Coming Soon!

While Epidiolex has been approved for release, the expected time to market is September 2018. A few things to know about the medication before it is released:

Effectiveness

The study for Epidiolex involved 3 randomized, double-blind, placebo controlled clinical trials which included 516 patients who had either Lennox-Gastaut Syndrome or Dravet Syndrome.3 Results showed that patients taking Epidiolex along with other anti-epileptic drugs (AEDs) showed a decrease in seizure frequency when compared to the placebo.3

Precautions

Side effects (3,5) are often something to be aware of before starting a new medication. A few reported side effects to Epidiolex include:

  • Elevated liver enzymes
  • Sedation
  • Lethargy
  • Sleep Disorders
  • Diarrhea
  • Rash
  • Increase in suicidal thoughts
  • Decrease in appetite
  • Abdominal discomfort
  • Abdominal pain

Cost

The company has not release any official information about cost for Epidiolex, however NY Times analysis estimates a cost of $2,500 to $5,000 a month.4 It is possible that this medication may be approved by insurances so make sure to discuss options with your provider.

Future Opportunities

Even though this medication is only currently approved for these two forms of seizures, it does open the door to future possibilities.  Always keep communication open with your healthcare provider so they can help guide you on therapy options as more clinical studies arise with new information.

 

References:

  1. Epilepsy Foundation. (2018). Dravet Syndrome. [online] Available at: https://www.epilepsy.com/learn/types-epilepsy-syndromes/dravet-syndrome [Accessed 11 Jul. 2018].
  2. Epilepsy Foundation. (2018). Lennox-Gastaut Syndrome (LGS). [online] Available at: https://www.epilepsy.com/learn/types-epilepsy-syndromes/lennox-gastaut-syndrome-lgs [Accessed 11 Jul. 2018].
  3. FDA.gov. (2018). FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. [online] Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm [Accessed 10 Jul. 2018].
  4. Kaplan, S. (2018). D.A. Panel Recommends Approval of Cannabis-Based Drug for Epilepsy. [online] Nytimes.com. Available at: https://www.nytimes.com/2018/04/19/health/epidiolex-fda-cannabis-marajuana.html [Accessed 5 Jul. 2018].
  5. Micromedexsolutions.com. (2018). Micromedex Products: Please Login. [online] Available at:
    http://www.micromedexsolutions.com/micromedex2/librarian/CS/B42F8E/ND_PR/evidencexpert/ [Accessed 5 Jul. 2018].

 


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