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by Mitchell Welton, PharmD Candidate 2019
University of Arizona

The use of marijuana draws a wide range of strong opinions out of people. Its advocates will tout all of its potential benefits of medical marijuana, while its opponents try to draw from the negative stigma that surrounds it. As in all hotly contested topics, the truth usually falls somewhere in between the opposing viewpoints. While the use of marijuana still remains illegal at the federal level, there are many states that have approved its medical use for qualifying individuals to treat certain conditions, and even fewer states have approved its recreational use.

California was the first state to legalize marijuana for medical use in 1996 and since then many states have followed suit. About a dozen states have legalized marijuana for medical use. The difference between medical and recreational use warrants its own discussion and the disagreement can be seen at a legislative level with more leniency being extended to medical over recreational. This author would generalize medical marijuana in this article as containing a higher concentration of CBD over THC, for all intents and purposes, in order to discuss medical marijuana compared to FDA approved cannabinoids.

Medical Marijuana (MMJ) Uses

The two chemicals of interest found in marijuana are tetrahydrocannabinol (THC) and cannabidiol (CBD) although the plant itself may contain up to 400 different chemicals. A recreational smoker would be looking for a higher concentration of THC which is the psychoactive component delivering the “high” that users seek. 1 CBD is the cannabinoid that doesn’t produce the “high” and has recently been approved by the FDA as an oral solution, called Epidiolex, to treat seizures. There are currently only three FDA approved, cannabinoid medications on the market. 2

The first of these medications was approved in 1985 by the FDA known as Marinol or dronabinol. A synthetic form of THC first approved for the treatment of chemotherapy induced nausea and vomiting. Its indication was expanded to include the treatment of weight loss and anorexia in people with AIDS. Other studies have found efficacy in achieving pain relief in patients with multiple sclerosis (MS) and treating other neuropathic pain. 3 Cesamet, or nabilone, is another synthetic cannabinoid that mimics THC also approved in 1985 for the treatment of chemotherapy induced nausea and vomiting with off label use to treat fibromyalgia shown in a 2011 systematic review of cannabinoids for chronic pain. 4 The third, Epidiolex, has already been mentioned which is the first FDA approved drug derived from marijuana. The previous two drugs where synthetic. Epidiolex is used in the treatment of two rare, but severe forms of epilepsy. 2

MMJ Safety Factors

There are multiple factors to consider when thinking of safety between the two types of marijuana. First that comes to mind is the administration. Let’s take dronabinol for example as it has been around the longest from an FDA approval standpoint and such has been examined in multiple studies. This is a liquid filled capsule taken by mouth. Like many oral medications it may take some time for it to be absorbed which means a delay in its effect. This is something to keep in mind as a quick onset of action would be preferred when treating nausea and vomiting. Once the capsule is taken by mouth and absorbed the next consideration is its excretion from the body.

Dronabinol has an elimination half life of 19 to 36 hours meaning there will be a therapeutic level of the medication in the blood for a significant period of time. Other considerations I would bring to attention of the reader is the environment in which the medication is produced. Part of the FDA requirement is the manufacturing standard the medication is subjected to. Conditions must be controlled in its production which would allow us to assume there would be little tainting or contamination. Lastly, this synthetic medication is a pure isomer of THC meaning the end user is not consuming the potential 400 other chemicals found in the marijuana plant which could account for less of a “high” from any other psychoactive cannabinoids. 5

Marijuana in contrast when smoked has a much more rapid onset of action however may be inappropriate for use in patients with asthma or COPD. Ingesting marijuana will have a slower onset and more unpredictable absorption. Once in the system the body would eliminate marijuana faster than dronabinol. Though its production is not regulated like the FDA approved medications, each state has its own laws limiting the cultivating of your own marijuana and licensing of larger cannabis farms. 5

No matter where you might stand on the issue, there is a place in healthcare for the use of marijuana. The question lies in the best way to regulate and manage it. It is important to always evaluate safety and efficacy with any treatment used. Patients should always be treated with evidence-based methods and in accordance to state and federal laws. For better or for worse marijuana, and its use, continues to garner support and opposition in larger numbers. This is a landscape that will continue to change as we look for developments in the application of its use.

 

References:

  1. What Is the Difference Between Medical and Recreational Marijuana? (2018, September 10). Retrieved from https://docmj.com/2017/06/05/difference-medical-recreational-marijuana/
  2. Office of the Commissioner. (n.d.). Press Announcements – FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. Retrieved from https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611046.htm
  3. Dronabinol: Marinol. (n.d.). Retrieved November 19, 2018, from Micromedex.
  4. Nabilone: Cesamet. (n.d.). Retrieved November 19, 2018, from Micromedex.
  5. Morrow, A. (n.d.). Marinol or Marijuana: Which Is Better? Retrieved from https://www.verywellhealth.com/is-marinol-better-than-smoked-marijuana-1132483

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Epidiolex: A new CBD epilepsy drug

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

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].

 


Download the free WellRx app from the iOS app store or the Google Play Store,
and get registered to take advantage of our free medication adherence tools.

If you’re struggling to afford your medications,
visit www.WellRx.com to compare the cash price at pharmacies near you.
You may find prices lower than your insurance co-pay!

 

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