Saturday January 4, 2020

By Andrew Ward

Sativex, Marinol and Epidiolex: FDA-Approved Cannabis Medicines Health/Science

After being used as a medical treatment for thousands of years, cannabis was prohibited and tossed to the side. Now, roughly one hundred years since global prohibition began, the world has already started to see the light and warm to the plant once again. As such, marijuana's potential value as a medicine has once again entered the picture. Scores of studies have been conducted to confirm the legitimacy of these cannabis claims, however, more research must be done before there is substantial evidence to use as proof. In the meantime, the U.S. Government does allow for several drugs to be sold and prescribed legally. Currently, the United States allows for three cannabis-related medicines to treat a select few patients. They are: Sativex, Marinol/Dronabinol, and Epidiolex.

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Sativex Side Effects, Information and Studies

Sativex is a cannabis-based oral spray medication using both THC and CBD as active components. The drug is used to address pains brought on by multiple sclerosis (MS). Sativex is the only drug approved for MS treatments in several countries, including Canada. The drug was approved by the U.S. Food and Drug Administration (FDA) in 2018. 

Side effects of Sativex include dry mouth, dizziness, drowsiness, fatigue and other issues related to one's memory and digestion. Patients are more likely to experience any side effects in the early portion of treatment.

As one of only a few approved cannabis medicines, Sativex has gone through rounds of research and continues to today. Early results in 2005 and 2006 showed that the drug provided "beneficial effects" on patient spasticity while also helping pain stemming from rheumatoid arthritis (RA). 

MS was often the focal point of studies. However, other conditions have been examined. They include cancer patients who did not respond to opioids. In the case of a 2017 study, Sativex proved ineffective in reducing pain. That said, analysis from 2019 suggested that the drug may reduce spasticity in people living with ALS.

Studies, Side Effects and Information on Marinol/Dronabinol

Marinol is a capsule-based drug used to treat nausea induced by chemotherapy as well as anorexia related issues brought on by AIDS. The drug, which uses a synthetic form of the cannabinoid THC known as dronabinol, comes in a variety of strengths, ranging from 2.5 mg to 10 mg with an average onset time of roughly 30 minutes. It was approved by the FDA in 1985.

marinol
Marinol is one of three cannabis-related medicines that are legal in the U.S. to treat a select few patients. photo credit

Most side effects are mild. They include stomach pain, difficulty concentrating and drowsiness. Patients can also develop side effects that affect their balance, mood and possibly hallucinate. In some cases, patients can experience seizures and possibly faint. 

Dronabinol has been the focus of lab studies for years. In 1990, an open study of 30 cancer patients found that the drug stimulated appetites. Weight studies would be the focus of other results in the following years. In most cases, weight gains were indicated, though some studies made a note of losses in weight when using THC. In recent years, researchers have called for additional studies to examine the drug some say has a "unique mechanism of action." 

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Epidiolex’s Effects and Studies

Epidiolex is a CBD-based oral solution used to address Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy. Approved by the FDA in 2018, Epidiolex is used to reduce the frequency of seizures in both conditions for patients aged two and up. 

Side effects can be minor to significant, depending on the instance. Patients may experience side effects, including liver issues and fatigue. They may also lead to suicidal thoughts, like other antiepileptic drugs, according to the FDA

Epidiolex has received its approval through several lab studies. Some tests cited in support of Epidiolex include a 2015 study funded by its creator, GW Pharmaceuticals. Findings conclude that CBD might reduce the frequency of seizures in children and young adults. A 2018 open study found similar results when used on four different types of childhood epilepsy forms. Research, which was conducted between 2014 and 2016, reported positive changes to patients with CDKL5 deficiency syndrome, Aicardi syndrome, Dup15q syndrome and Doose syndrome. 

Next Steps for FDA-Approved Cannabis Medicines

These three drugs represent a glimmer of hope for families who otherwise have little to none. While there is hope that cannabis, be it the plant, pharmaceuticals or otherwise, is found to be legitimate medicine, we may not see another approved in the United States anytime soon. 

As of late, the government has been more inclined to take cautionary stances towards cannabis. This includes the Food and Drug Administration (FDA) warning consumers not to vape THC in light of the recent deaths and health concerns believed to largely stem from illicit market cartridges. The FDA also urged parents to avoid using cannabis while pregnant, despite many doing so.

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The FDA is still in the process of approving CBD. photo credit

Meanwhile, CBD is in the spotlight as lawmakers continue to hammer out its laws. With laws appearing closer to completion than ever before, progress could lead to additional medicines reaching the market soon enough. That said, consider that merely speculation at this time. 

While little progress is made regarding cannabis medicine, the emergence of Big Pharma into cannabis is well underway. This includes the strategic partnership between pharma giant Novartis and Canada's Tilray in 2018. More recently, pharma leader Teva Pharmaceuticals signed a distribution deal with Canndoc to deliver products to several locations in Israel. While the future remains to be seen, these three drugs may one day serve as the tipping points in on the topic.


Have you used or do you know anyone who has used Sativex, Marinol or Epidiolex? Share your experiences in the comments below.

Photo Credit: freestocks.org (license)


Andrew Ward Andrew Ward

Andrew Ward is a Brooklyn-based cannabis writer and creative. His work has appeared on Benzinga, High Times, PROHBTD and several other publications and brand blogs. He has covered the cannabis space for over three years, and has written professionally since 2011. His first book, "Cannabis Jobs," was released in October 2019. Connect with Andrew on LinkedIn to stay up to date.



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