Hallway Conversation on FDA Committee Review of Epidiolex

Hallway Conversations

Epilepsy News From:

Monday, May 7, 2018

In this episode of Hallway Conversations, epilepsy.com Editor-In-Chief Dr. Joseph Sirven interviews Dr. Jose Cavazos MD, PhD, professor of neurology at the University of Texas Health Science Center in San Antonio. They discuss Dr. Cavazos’ experience serving as a panelist on the recent U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drug Advisory Committee review of Epidiolex® for the treatment of Dravet and Lennox-Gastaut syndromes.

  • Epidiolex is a purified, 99% oil-based cannabidiol (CBD) extract from the cannabis plant and is produced by GW Pharmaceuticals to give known and consistent amounts in each dose.
  • The Advisory Committee concluded with a unanimous vote to recommend approval of Epidiolex, the first drug derived from cannabis plant in the U.S.

Listen to Learn

  • What is it like to serve on an FDA review panel?
  • How was Dr. Cavazos selected as a panelist?
  • Who else served on the panel?
  • What is an expedited review?
  • What studies did the panel review?
  • How does the panel work? What does it do?
  • What kinds of recommendations does the panel make to FDA?
  • What did the panel find related to Epidiolex?
  • During Dr. Cavazos’ review of Epidiolex, was he surprised by any information about its effectiveness and how it works? Were there differences in how it works in various populations?
  • What does Dr. Cavazos predict will happen related to the Drug Enforcement Agency classification of cannabidiol?
  • Where there any surprises in the side effects found?
  • What important point should audience members remember about today’s Hallway Conversation discussion?
Hallway Conversations on FDA Panel

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The mission of the Epilepsy Foundation is to lead the fight to overcome the challenges of living with epilepsy and to accelerate therapies to stop seizures, find cures, and save lives.

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