WILL CBD FOR SEIZURES RECEIVE FDA APPROVAL SOON?

February 21, 2021

In the lengthy battle for FDA approval for cannabis-based medication, we may soon have a new approval! Epidiolex is a purified version of CBD for the treatment of seizures in pediatric-onset treatment-resistant epilepsies (TREs) which GW Pharmaceuticals has been testing. The 13-member board of federal health advisors gave their nod of approval earlier this year. The FDA is set to make a decision by late June.

POSITIVE RESEARCH SURROUNDING CBD FOR SEIZURES

Through clinical studies, CBD oil has been showing remarkable effects in helping children who suffer from rare forms of epilepsy that do not respond well to conventional epileptic medications. Most recently, a 2017 study showed children who were given CBD in addition to their other prescriptions for epilepsy had a decrease in the frequency of convulsive seizures (those producing loss of consciousness, stiffened muscles and jerking movements). They had a decrease of 23 percentage points more than the decrease in seizures in children taking a placebo. GW Pharmaceuticals helped fund this study.

Dr. Orrin Devinsky, the lead author of the study and director of NYU Langone's Comprehensive Epilepsy Center, said, "After 3,800 years of cannabis use for epilepsy...we finally have solid evidence." His previous research had unearthed indications that cannabis has been used for the treatment of epilepsy since 1800 BC in Samaria. Also, Victorian physicians used Indian hemp for the same purpose.

USING CBD FOR DRAVET SYNDROME AND OTHER FORMS OF EPILEPSY

Dravet syndrome is a severe form of epilepsy involving multiple types of seizures, developmental delays, speech and language problems, movement and balance problems, and behavioral issues. Epilepsy medications normally used today do not work effectively on patients with Dravet syndrome. Up to 20% of children who are diagnosed with this rare form of epilepsy die from seizures before age 20.

In this study, Dravet patients using CBD had a significant decrease in seizures compared to those who received a placebo. The result of the two week study showed those receiving CBD had episodes of convulsive seizures drop an average of 12.4 to 5.9 a month. Those receiving the placebo had a only a slight decrease, from 14.9 to 14.1 per month.

Other recent studies have shown agreement with Dr. Devinsky. The outcomes of interest from using CBD as an adjunctive treatment include up to a 50% decrease of seizures, complete freedom from seizures, and improved quality of life. However, there was also an increase in side effects. Their conclusion was simply, "Pharmaceutical-grade CBD as adjuvant treatment in pediatric-onset drug-resistant epilepsy may reduce seizure frequency."

It is unknown if CBD would be effective for people with other types of epilepsy. Also, while the results of the above-mentioned studies have been positive, there were also some reports of side-effects from study participants who received CBD. Because of this, we realize additional work is needed before CBD can become a routine part of clinical practice.

WILL CBD'S HEALTH BENEFITS LEAD TO FDA APPROVAL?

What is known is that CBD does have health benefits. It is found in the hemp part of the marijuana plant and contains so little THC that it is not psychoactive. Studies have shown CBD significantly decreases inflammation causing pain in mice and rats. There is promising evidence it may help people stop smoking. Researchers have noted it may reduce anxiety, mood symptoms, pain, and insomnia experienced by patients with substance-abuse disorders.

Hopefully the FDA will approve Epidiolex at the end of June for treating TREs. Beyond that, continuing research should give more solid data for additional cannabidiol pharmaceutical-grade medications in the future. Until then, we offer CBD Tincture for your use as a supplement.