FDA approves epidiolex for severe forms of epilepsy

FDA approves epidiolex for severe forms of epilepsy

(HealthDay)—The U.S. Food and Drug Administration has approved Epidiolex (cannabidiol) oral solution for treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome for patients age 2 years and older.

The rare, genetic Dravet syndrome appears during the first year of life with frequent fever-related seizures; other types of seizures arise later, and status epilepticus may occur. Lennox-Gastaut syndrome begins in childhood and is characterized by multiple types. Frequent seizures begin in early childhood, usually between ages 3 and 5.

The effectiveness of Epidiolex was examined in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with Lennox-Gastaut or Dravet . When taken with other medications, Epidiolex reduced the frequency of seizures compared with placebo. The most common side effects observed in patients treated with Epidiolex were sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise, and weakness; insomnia, sleep disorder, and poor sleep quality; and infections.

"In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a specifically for Dravet will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition," Billy Dunn, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a statement.


Explore further

Cannabidiol significantly reduces seizures in patients with severe form of epilepsy

More information: More Information

Copyright © 2018 HealthDay. All rights reserved.

Citation: FDA approves epidiolex for severe forms of epilepsy (2018, June 28) retrieved 17 July 2019 from https://medicalxpress.com/news/2018-06-fda-epidiolex-severe-epilepsy.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
3 shares

Feedback to editors

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more