On April 19, the FDA unanimously endorsed Epidiolex; a prescription syrup for children with severe epilepsy that rarely responds to other epilepsy medications. Epidiolex contains CBD as an active ingredient that acts to reduce epileptic seizures by over 20% without getting users high. CBD does not contain THC; the cannabis derivative that causes the much sort after high.
The FDA panelists endorsed the prescription medication based on three studies that portrayed the drug’s significance at reducing seizures in children with two rare types of childhood epilepsy. Dr. John Mendelson, a panelist at the Friends Research Institute in Baltimore labelled Epidiolex as a breakthrough drug for an awful childhood disease. Epidiolex is a CBD oil or cannabidiol pharmaceutical grade version that some parents living in marijuana legalized states have been using to treat children with epilepsy.
GW Pharmaceuticals PLC CEO, Justin Gover said that the company was pleased by the unanimous panelists’ support of Epidiolex approval. He further added that it was a milestone that signified a breakthrough in the epilepsy research and treatment field. Being the first CBD based pharmaceutical to be approved by FDA, it signifies the onset of a new treatment class that utilizes a new epilepsy treatment mechanism.
Though FDA regulators are set to make their decision in June, approval of the prescription medication would be limiting. Epidiolex will be limited to patients with hard to manage and treat epilepsy types. However, it would spur detailed pharmaceutical research and give doctors an option to prescribe it for other uses.
It should be noted that, the drug contains potential risks like liver damage. Hence, FDA panelists recommended that doctors should monitor patients closely for any health complications signs. Other side effects include; sleep problems, fatigue, diarrhea and vomiting. Patients will also be monitored for side effects when used in conjunction with other medications.