LANDOVER, MD, September 27, 2018 — We are pleased to hear that the U.S. Drug Enforcement Administration (DEA) placed Epidiolex® at Schedule V in line with the U.S. Food & Drug Administration’s (FDA) scheduling recommendation. People with epilepsy who are unable to obtain seizure control with existing treatments are at a higher risk of accident, injury, hospitalization, and even death. The DEA’s rescheduling of Epidiolex®, the first ever drug derived from cannabidiol (CBD) approved to treat Dravet and Lennox-Gastaut syndromes (LGS), is a tremendous milestone for some of these most vulnerable individuals who now may have access and hope of gaining better seizure control.
On June 25, 2018, the FDA approved Epidiolex for the treatment of Dravet and Lennox-Gastaut syndromes (LGS), two rare and severe forms of epilepsy. The DEA had 90 days from approval to schedule the medication because CBD is a Schedule I substance. Under the Controlled Substances Act, the DEA has the authority to classify drugs, substances, and certain chemicals used to make medications into five distinct categories, or schedules, depending upon the drug’s acceptable medical use and the drug’s abuse or dependency potential. Medical value and abuse potential determinations are informed by large-scale clinical trials conducted under the guidance of the FDA. After evaluation by the Center for Drug Evaluation and Research, the FDA determined there was negligible abuse potential for this treatment and placed Epidiolex on Schedule V.
Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV and consist of limited quantities of certain narcotics which are known to cause dependency.
The Epilepsy Foundation has brought together the epilepsy community to advocate for changes in the remaining states where scheduling laws need to be changed to allow therapies derived from CBD and approved by the FDA to become available to people living with epilepsy in a timely manner. Therapies derived from CBD show promise for people living with uncontrolled seizures and rare epilepsies. Even with FDA approval, any new therapies derived from CBD would not be available unless states implement changes to state scheduling laws, even if the state has a medical cannabis program.
For more information about what this announcement means for our community, please visit: http://bit.ly/2zAn55l.
According to the World Health Organization, epilepsy is the most common serious brain disorder worldwide with no age, racial, social class, national or geographic boundaries. The U.S. Centers for Disease Control & Prevention (CDC) estimates that 3.4 million people in the United States are affected by epilepsy. It is the underlying tendency of the brain to produce seizures which are sudden abnormal bursts of electrical energy that disrupt brain functions.
About the Epilepsy Foundation
With a network of nearly 50 partners throughout the United States, the Foundation connects people to treatment, support and resources; leads advocacy efforts; funds innovative research and the training of specialists; and educates the public about epilepsy and seizure first aid. For more than five decades, the Epilepsy Foundation has shone a light on epilepsy to promote awareness and understanding, and to advocate for laws that matter to people with epilepsy, while also funding $65 million for epilepsy research and supporting 3,076 epilepsy investigators and specialists in their early careers. Over the past 17 years, in partnership with the CDC, the Epilepsy Foundation has helped to improve access to care for people with epilepsy, expanded its digital reach and online resources in homes across the country, and trained more than 500,000 school and community personnel in how to recognize seizures and administer Seizure First Aid. The Foundation has also assisted more than 108,000 people through its 24/7 Helpline in the past five years, and continues to focus on innovation, new therapies, community services, advocacy and education as key priorities. To learn more, visit epilepsy.com or call 800-332-1000. Follow us on Facebook and Twitter.
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