Cannabis-Derived Drug Gets Nod From FDA Committee

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Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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In April, the Food and Drug Administration advisory committee met and recommended the approval for Epidiolex, the first plant-derived cannabidiol prescription medicine for use in the United States. While this is just one more step in the approval process, if the FDA approves Epidiolex in June, we could see it on the market in the coming year. While the FDA does not have to follow recommendations from the advisory committee, it strongly takes their recommendations into consideration.

Epidiolex is sponsored by GW Pharmaceuticals for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

What is a cannabidiol (CBD)?

Cannabidiol (CBD) is a non-psychoactive cannabinoid which may have anti-inflammatory, analgesic, and antipsychotic properties. It may help with spasticity, epilepsy, and nausea but does not appear to induce euphoria.

Epidiolex would be the 1st prescription medication in the United States made from the cannabis plant and the 1st medication in a new category of anti-seizure drugs.

What is Lennox-Gastaut syndrome?

Lennox-Gastaut syndrome is a pediatric epilepsy syndrome characterized by multiple seizure types, regression, and abnormal findings on electroencephalography (EEG), which is a monitoring method to record the electrical activity of the brain.

What is Dravet syndrome?

Dravet syndrome previously known as severe myoclonic epilepsy of infancy (SMEI), is a type of epilepsy with seizures that are often triggered by hot temperatures or fever. It is a rare genetic dysfunction of the brain that begins in the 1st year of life in an otherwise healthy infant and is lifelong.

Does GW Pharmaceuticals have any other cannabinoid products?

Yes. GW Pharmaceuticals developed the world’s first cannabinoid prescription drug, Sativex, which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States. GW Pharmaceuticals also has other cannabinoid products in their pipeline which include compounds in development for epilepsy, glioma, and schizophrenia.

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