June 26, 2018
After a long overdue, the has finally approved a drug derived from cannabis. Epidiolex is a medication for epileptic seizures that have CBD as its main ingredient. Before that, the FDA has approved several medications containing synthetic derivates of cannabis.
However, this is the first time when a drug derived from organic extracts of cannabis flower has been approved by the FDA. Epidiolex is developed and manufactured by a UK-based pharmaceutical company GW Pharmaceuticals.
The drug was actually researched for its therapeutic effects on children suffering from epilepsy. The company started to manufacture the drug last year after extensive trials. Epidiolex is a non-psychoactive drug with extremely minor (less than 0.1 percent) traces of THC. It is among those hundreds of cannabinoids that make up cannabis. The intoxicating feature of pot is attributed to the amount of THC in it. For that reason, cannabis strains are classified as a controlled substance.
The agency has approved the drug after making it certain that its benefits outweigh the side effects for children two years and above suffering from severe forms of epilepsy.
FDA is Considering to Approve More Cannabis-Based Drugs
With the approval of Epidiolex, the drug regulatory agency is also considering approving a couple of other cannabis-based drugs. For instance, there is another cannabis-derived medicine in the making for treating two severe forms of epilepsy (Dravet Syndrome and LGS).
According to one the agency’s commissioner, Scott Gottlieb, they will certainly approve other MMJ treatments that are compliant to the agency’s regulatory process. He says that the FDA welcomes all the cautious scientific research on the active organic compounds present in cannabis that can be used for therapeutic purposes.
MMJ Medications for Epilepsy Bring Hope
Regular medical treatments for epilepsy are not that effective. Moreover, they inflict severe side effects on patients. For that reason, an FDA-approved MMJ medication for epilepsy will definitely bring hope for patients and their caregivers.
Dr. Elizabeth Thiele takes care of pediatric epilepsy department at Massachusetts General Hospital and also teaches neurology at Harvard Medical School. She was also part of the primary researcher’s board of GW study. She is hopeful that parents of epileptic children have found an effective alternative in the form of Epidiolex. It is not a secret anymore that CBD-based drugs are being used to treat epilepsy in almost every state where medical cannabis is legal.
FDA Approval Might Lead to Reclassification of Cannabis
As the things stand, cannabis and all its cannabinoids are classified as a schedule I controlled substance in federal legislation. But with developments such as this, one can hope that federal lawmakers might consider reclassifying marijuana.
A piece of legislation that calls for reclassification of cannabis is already pending in Congress. Developments like these where federal agencies approving the use of MMJ have more potential for persuading lawmakers to reconsider the status of cannabis as a drug. Experts think that reclassification of cannabis will give way to more research and studies on the therapeutic effects of marijuana.