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Epidiolex is a prescription medication primarily used for the treatment of seizures associated with certain severe forms of epilepsy. It is made from cannabidiol (CBD) that is extracted and purified from the Cannabis sativa plant.[1] This makes it the first FDA-approved medication to contain an active ingredient directly derived from cannabis.[2]

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Initially, due to its cannabis origin, Epidiolex was classified as a Schedule I controlled substance by the Drug Enforcement Administration (DEA). However, following its approval by the U.S. Food and Drug Administration (FDA) in 2018 for medical use, the DEA reclassified Epidiolex to Schedule V in September 2018.[3] This reclassification acknowledged its established medical utility and low potential for abuse compared to other controlled substances.[4] Further, in April 2020, the DEA removed Epidiolex from the federal schedules of controlled substances entirely, effectively descheduling it. This means that Epidiolex is no longer subject to federal controlled substance restrictions, reflecting its unique status as a cannabis-derived medication with proven efficacy and safety for specific medical conditions.[5]

Key Characteristics of Epidiolex

  • Active Ingredient: The primary active ingredient in Epidiolex is cannabidiol (CBD), a non-psychoactive cannabinoid found in the cannabis plant.[1] Unlike tetrahydrocannabinol (THC), CBD does not produce the "high" associated with cannabis use.[6]
  • FDA Approval: Epidiolex received FDA approval in June 2018 for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients two years of age and older.[2] In July 2020, its approval was expanded to include the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older.[7]
  • Mechanism of Action: While the precise mechanism of action of CBD in treating epilepsy is not fully understood, it is believed to involve multiple pathways, including modulation of neurotransmitter systems, anti-inflammatory effects, and interaction with various receptors in the brain.[8]
  • Dosage and Administration: Epidiolex is an oral solution, and its dosage is carefully titrated by a healthcare professional based on the patient's weight and response to treatment.[1]
  • Side Effects: Common side effects can include somnolence, decreased appetite, diarrhea, and elevated liver enzymes.[1] Regular monitoring by a physician is necessary to manage potential side effects.

Regulatory Journey

The journey of Epidiolex from a cannabis-derived compound to a descheduled prescription medication highlights a significant shift in the regulatory landscape surrounding cannabis and its derivatives. The FDA's rigorous approval process, which requires extensive clinical trials to demonstrate safety and efficacy, was crucial in establishing Epidiolex as a legitimate therapeutic agent.[2] The subsequent DEA reclassification and descheduling underscore the distinction between scientifically validated cannabis-derived medicines and recreational cannabis products.[5]

Authoritative Sources

  1. EPIDIOLEX (cannabidiol) oral solution. [FDA]↩
  2. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. [U.S. Food and Drug Administration (FDA)]↩
  3. DEA Reschedules Epidiolex to Schedule V. [Drug Enforcement Administration (DEA)]↩
  4. DEA Final Rule: Schedules of Controlled Substances: Placement of Cannabidiol in Schedule V. [Federal Register]↩
  5. DEA Removes Epidiolex from Schedule V. [National Law Review]↩
  6. What Is CBD? [Centers for Disease Control and Prevention (CDC)]↩
  7. FDA approves new indication for Epidiolex. [FDA]↩
  8. Cannabidiol: Pharmacology and Potential Therapeutic Role in Epilepsy. [PubMed Central (PMC)]↩

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