This Is The World's First FDA-Approved CBD Medication
FDA officials finally approved the world’s first CBD-based drug, Epidiolex, developed by pharmaceutical-maker by GW Pharmaceuticals. The drug is designed for use in treating two severe forms of childhood epilepsy and is the very first FDA-approved medication that contains a purified cannabinoid derived from cannabis. Moreover, it is the first FDA approval of any drug specifically meant to treat Dravet syndrome, one of the aforementioned forms of epilepsy. The approval comes on the heels of a panel of FDA advisers unanimously recommending the agency approve Epidiolex back in April.
Epidiolex is an oral solution which is used to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, two extremely severe and rare forms of childhood epilepsy. Both conditions develop in childhood and are life-threatening, causing frequent seizures. Moreover, both are resistant to currently approved antiepileptic drugs and require treatment with multiple anti-seizure medications. Epidiolex is meant to be used by patients two years and older.
The director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, Dr. Billy Dunn said in a statement, “The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life. In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide significant and needed improvement in the therapeutic approach to caring for people with this condition.”
The FDA’s approval was based on data from three clinical trials involving 516 patients afflicted with either form of epilepsy. Results from the trials proved that Epidiolex, taken in conjunction with other antiepileptic medications, reduced the frequency of seizures, though some adverse reactions were reported. Conversely, CBD oil on its own is not known to have any adverse reactions.
“In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD,” said Dr. Orrin Devinsky, the lead investigator in the Epidiolex clinical program. “I am delighted that my physician colleagues and I will now have the option of a prescription cannabidiol that has undergone the rigor of controlled trials and been approved by the FDA to treat both children and adults.”
Epidiolex has also been granted orphan drug designation from the FDA for the treatment of tuberous sclerosis complex and infantile spasms, according to reports from GW Pharmaceuticals. For Epidiolex to be made available to patients, it must be rescheduled from its current Schedule I status, which is expected to occur within 90 days.