FDA Approves Epidiolex, First Cannabis-Based Medication for Epilepsy in U.S

The U.S. Food and Drug Administration (FDA) has made a groundbreaking decision by approving Epidiolex, the first cannabis-derived medication to be available in the United States. This medication is specifically intended for children over the age of two who suffer from two severe forms of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome (LGS)

Both Dravet syndrome and LGS are known for causing frequent and severe seizures, which can significantly impact a child's cognitive and motor development. The approval of Epidiolex brings hope to families affected by these conditions, offering a new avenue for managing these debilitating seizures

Philip Gattone, president of the Epilepsy Foundation, hailed the approval as a significant medical advancement for those with treatment-resistant seizures. He emphasized the importance of continued clinical research into rare and severe disorders, highlighting the hope that Epidiolex offers to patients and their families

Epidiolex is a strawberry-flavored syrup that contains 98% cannabidiol (CBD) and less than 0.1% tetrahydrocannabinol (THC). Developed by GW Pharmaceutical in the UK, the drug's release in the U.S. now hinges on the Drug Enforcement Administration (DEA) reclassifying CBD, which is currently in Schedule I, a category that does not recognize its therapeutic value

The efficacy of Epidiolex was demonstrated in three randomized, placebo-controlled clinical trials involving 516 patients with Dravet syndrome or LGS. These trials showed a significant reduction in seizure frequency, leading a panel of FDA advisors to recommend its approval in April. As the DEA reviews the classification of CBD, the medical community and families await the final steps before Epidiolex becomes widely available