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DEA Removes CBD-Based Epidiolex From The Controlled Substance List

June 22, 2020 in Cannabis Law

Epidiolex is an FDA-approved drug derived from cannabis used to treat seizures associated with epilepsy. It was approved two years ago by the US Food and Drug Administration (USDA) and placed on the Controlled Substance List (CSA) as a Schedule V drug. In April, 2020 it was removed completely from the list. In this article I will explain what Epidiolex is, the conditions that it treats and the implications for other uses as well as the timeline of its approval and its removal from the CSA.

Facts About Epidiolex

On June 25, 2018 CBD-based Epidiolex was approved by the USDA as a treatment for adults and children two years and older to control the seizures linked with two intractable, rare forms of epilepsy; Dravet Syndrome and Lennox-Gastaut Syndrome. The first FDA approved drug for Dravet Syndrome, Epidiolex is produced by extracting large quantities of cannabidiol (CBD) from cannabis plants. It became available for use in the US on November 1, 2018.

Dravet Syndrome

Dravet Syndrome is a genetic condition that typically occurs during the first 12 months of life, presenting with frequent febrile seizures. As the child ages, additional types of seizures begin to occur. This includes involuntary muscle spasms known as myoclonic seizures and status epilepticus in which seizures often are continuous, life-threatening and require emergency medical intervention. Those with Dravet Syndrome have retarded and poorly developed language and motor skills, are hyperactive and cannot relate to others.

Lennox-Gastaut Syndrome

Lennon-Gastaut Syndrome typically does not present until the child is between ages 3 and 5. It is distinguished by the occurrence of multiple types of seizures. More than 75% of those with the syndrome experience tonic seizures which causes the uncontrollable contraction of muscles. The majority of those affected have learning and intellectual disabilities. Many also have developmental delays of motor skills. As a result, they need constant assistance with the daily tasks of self-care.

In both cases, difficulty in controlling the seizures has a profound effect on the quality of life of these patients.

Epidiolex

Prior to its FDA approval, the efficacy of Epidiolex was evaluated in three different randomized, double-blind, placebo controlled clinical trials using 516 patients with both Lennox-Gastaut and Dravet Syndrome. In the studies, most of the participants were taking at least 2 other antiseizure medications in conjunction with Epidiolex.

The results were as follows:

  • There was a decrease in the frequency of seizures by 26% for those with Dravet Syndrome when compared to those not taking the drug.
  • There was a decrease in the frequency of seizures by 20% to 25% for those with Lennox-Gastaut Syndrome when compared to those not taking the drug.

DEA Deschedules Epidiolex

In April, 2020 the US Drug Enforcement Administration (DEA) at the behest of GW Pharmaceuticals, makers of Epidiolex, removed the antiepileptic CBD oral solution from the list of controlled substances. The change is effective immediately. The spokesman for GW Pharmaceuticals announced that the company will start the process of making these changes at the state level as well as through the product’s distribution network.

This decision means that all federal controlled-substance restrictions have been lifted from the product. However, patients will still be required to get a prescription from a doctor, valid for 1 year and may transfer it from one pharmacy to another. This also gives physicians the ability to prescribe the medication without the constraints of state prescription drug monitoring programs.

It is interesting to note that when the FDA approved the medication in 2018, the agency felt that it should be removed completely from the CSA.  It viewed CBD as a very low risk drug with many known health benefits.  The DEA insisted that it remain on the CSA in Schedule V. Cannabis is still on the Schedule I list. The DEA blamed international treaty obligations for its need to remain on the CSA. In 2019, the World Health Organization (WHO) disagreed, pointing out that CBD which contains no more than 0.2% THC was “not under international control.”

What Are Schedule V Drugs?

Schedule V drugs are typically used for antidiarrheal, antitussive and analgesic purposes. They include:

  • Robitussin AC – cough syrups with less than 200 mg of codeine/ml
  • Lomotil
  • Motofen
  • Lyrica
  • Parepectolin

Implications For Other Uses

In February, 2020 GW Pharmaceuticals and its US subsidiary Greenwich Biosciences Inc submitted a New Drug Application to expand the use of Epidiolex to include the seizure activity associated with tuberous sclerosis complex.

What Is Tuberous Sclerosis Complex?

Tuberous sclerosis complex is a genetic disorder most notably defined by the appearance of many benign tumors that can be found in many parts of the body, but especially on the skin. Other areas typically affected are in the brain, the kidneys and other organs. It may cause significant health problems.

The most common feature of the disorder is the skin abnormalities which include patches of very light-colored skin, raised and thickened areas of skin and tumors under the nails. Beginning in childhood, many patients develop angiofibromas which are tumors on the face.

Tuberous sclerosis complex often causes seizures, hyperactivity and aggressive behaviors as well as learning disabilities and intellectual delays. It is not uncommon for those with the disorder to develop brain tumors which have the potential to cause serious or life-threatening problems. Some of the children with the disorder are on the autism spectrum.

In a statement, the CEO of GW Pharmaceuticals, Justin Gover, thanked the DEA for removing the drug from the CSA on behalf of patients living with Dravet Syndrome and Lennox-Gastaut. “The descheduling of Epidiolex has the potential to further ease patient access to this important therapy…

This development is a positive step towards legitimizing cannabis as a potential life-saving medicine.

Sources:
marijuanamoment.net, CBD Prescription Drug Is No Longer A Federally Controlled Substance, DEA Says, April 6, 2020, Kyle Jaeger
drugtopics.com, DEA Deschedules Antiepileptic CBD Oral Solution Epidiolex, April 7, 2020
medicalnewstoday.com, Epidiolex,article 326061
ghr.nlm.nih.gov, Tuberous Sclerosis Complex

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