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FDA approves Epidiolex, first medication derived from marijuana

Photograph by Tim Bishop

 

The U.S. Food and Drug Administration has approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet Syndrome. This is the first plant-derived cannabinoid prescription medicine.

Lennox-Gastaut Syndrome and Dravet Syndrome, which develop in childhood, are rare, severe forms of epilepsy. Many patients with LGS and Dravet syndrome require multiple seizure medications and the majority are resistant to currently approved anticonvulsant medications.

What is Dravet Syndrome

According to the Dravet Syndrome Foundation, Dravet syndrome is a rare, catastrophic, lifelong form of epilepsy that begins in the first year of life with frequent and/or prolonged seizures. Previously known as Severe Myoclonic Epilepsy of Infancy (SMEI), it affects 1:15,700 individuals, 80% of whom have a mutation in their SCN1A gene. “We are very pleased to see the approval of EPIDIOLEX® for Dravet and Lennox-Gastaut Syndromes, says Dravet Syndrome Foundation executive director Mary Anne Meskis. “While each of our disorders are different in terms of etiology, both of our communities suffer from intractable seizures, an increased risk of mortality, and many devastating co-morbid conditions that significantly affect quality of life.” For more on Dravet Syndrome, visit the foundation’s website at https://www.dravetfoundation.org.

What is Lennox-Gastaut Syndrome

According to Christina SanInocencio, Executive Director of the LGS Foundation, “Today’s announcement gives individuals with Lennox-Gastaut Syndrome and their families much needed hope.” Lennox-Gastaut Syndrome (LGS) is a rare and often debilitating form of childhood-onset epilepsy. The syndrome is characterized by a triad of signs including multiple seizure types, moderate to severe cognitive impairment, and an abnormal EEG with slow spike-wave complexes.  This triad of mixed seizures, abnormal EEG and intellectual impairment represents one of the most difficult forms of epilepsy to treat. LGS is also a physically dangerous epilepsy syndrome of childhood because of the frequent falls, injuries, and cognitive impairment that can severely limit quality of life. For more information on Lennox-Gastaut Syndrome visit http://www.lgsfoundation.org.

EPIDIOLEX to patients

“We have tried many medications for Spencer’s seizures, and all failed. While LGS seizures are intractable and Epidiolex is yet another medicine, I am hopeful. It has proven helpful enough to obtain FDA approval, and perhaps my child can benefit as well,” notes Elizabeth, mom to Spencer.

According to a release from the company that makes the drug, “EPIDIOLEX will be marketed in the U.S. by Greenwich Biosciences, the U.S. subsidiary of GW Pharmaceuticals plc. As part of the approval process, EPIDIOLEX must be rescheduled from its current Schedule I before it can be made available to patients. Rescheduling is expected to occur within 90 days. Access is expected to be similar to other branded antiepileptic drugs and EPIDIOLEX is expected to be available to appropriate patients by Fall 2018.”

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