FDA Declares Cannabis Drug Epidiolex No Longer A Controlled Substance

The U.S. Drug Enforcement Administration (DEA) confirmed that the GW Pharmaceuticals plc (Nasdaq: GWPH) cannabidiol drug Epidiolex is no longer subject to the Controlled Substances Act (CSA). The DEA’s letter means that all federal controlled-substance restrictions have been removed for Epidiolex. This change takes effect immediately.

The stock was rising over 3% to lately trade at $85.06 on the news. This further lifts the stock from its 52-week low of $67.98.

“This notification from DEA fully establishes that Epidiolex, the only CBD medicine approved by FDA, is no longer a controlled substance under the federal Controlled Substances Act,” said Justin Gover, GW’s Chief Executive Officer.  “We would like to thank DEA for confirming the non-controlled status of this medicine. Importantly, the descheduling of EPIDIOLEX has the potential to further ease patient access to this important therapy for patients living with Lennox-Gastaut Syndrome and Dravet syndrome, two of the most debilitating forms of epilepsy.”

In 2018, the FDA approved Epidiolex for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet syndrome in patients two years of age or older. It is the first prescription pharmaceutical formulation of highly purified, plant-derived cannabidiol (CBD), and the first in a new category of anti-epileptic drugs. At the time, the approval was groundbreaking as the DEA has classified cannabis as a schedule 1 drug meaning there was medicinal purpose for the substance. By approving the drug as a medicine, it turned this argument upside down. Today’s news further refutes the claim that cannabis should remain a schedule 1 drug.

Following FDA approval, Epidiolex was initially placed in Schedule V of the CSA. Following receipt of this DEA notification, GW has filed a post-approval supplement with FDA to remove Schedule V designation from Epidiolex.

The company said in a statement that once this process is completed in each state, prescriptions for Epidiolex, like other non-controlled medicines, will be valid for one year and can be easily transferred between pharmacies. The descheduling of Epidiolex also enables physicians to prescribe this breakthrough medicine free of the requirements of state prescription drug monitoring programs.

The medicine is marketed in the United States by Greenwich Biosciences, the U.S. subsidiary of GW Pharmaceuticals plc. The company said it will now begin the process of implementing these changes at the state level and through the EPIDIOLEX distribution network.

Debra Borchardt

Debra BorchardtDebra Borchardt

Debra Borchardt is the CEO, Co-Founder, and Editor-In-Chief of GMR. She has covered the cannabis industry for several years at Forbes, Seeking Alpha and TheStreet. Prior to becoming a financial journalist, Debra was a Vice President at Bear Stearns where she held a Series 7 and Registered Investment Advisor license. Debra has a Masters degree in Business Journalism from New York University.


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