The debate over medical marijuana is far from settled. However, with the FDA’s approval of GW Pharmaceuticals’ Epidiolex, which contains an active ingredient derived from marijuana, the conversation surrounding the controversy can be expected to change.
Epidiolex, which contains CBD, a chemical component of the Cannabis sativa plant, is approved for the treatment of two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.
While the drug contains CBD, one of more than 100 chemicals found in marijuana, it does not contain tetrahydrocannabinol (THC), the element responsible for the intoxication—or the “high”—associated with the substance. Patients who take Epidiolex should not experience psychoactive side effects.
FDA Commissioner Scott Gottlieb, M.D. commented on the approval, referring to it as “a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.” He added that “the FDA is committed to this kind of careful scientific research and drug development.”
Both Dravet syndrome and Lennox-Gastaut syndrome appear in early childhood, with Dravet syndrome developing in the first year of life and Lennox-Gastaut syndrome a few years later, typically between the ages of three and five.
Both are characterized by sever seizures that range in type, including myoclonic seizures, tonic seizures, and in the case of Dravet syndrome, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care.
Suffers from both syndromes are incredibly likely to develop language and learning problems and intellectual disabilities, as well as delayed development of motor skills. Most people living with Lennox-Gastaut syndrome require assistance performing every day activities.
This May 23, 2017 file photo shows GW Pharmaceuticals’ Epidiolex, a medicine made from the marijuana plant but without THC. U.S. health regulators on Monday, June 25, 2018, approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use. (AP Photo/Kathy Young)
“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,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”
Epidiolex was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients. When taken in combination with other medications, Epidiolex demonstrated effectiveness in reducing the frequency of these life-altering seizures when compared with the placebo treatment.
Epidiolex is essentially a pharmaceutical-grade version of CBD oil, a product already commonly used to treat afflictions like seizures. Because of this, FDA recognition and regulation of medication like Epidiolex is crucial because, as Dr. Ellaine Wirrell, director of the Mayo Clinic’s program for childhood epilepsy, states, there is now “a product that will be cleaner and one that [we] know what it is. In the artisanal products there’s often a huge variation in doses from bottle to bottle depending on where you get it.”
The official approval and commercialization of a CBD product puts parents of children who suffer from such illnesses as ease. One such parent, Allison Hendershot, whose 13-year-old daughter, Molly, has suffered from severe seizures since she was four months old, commented, “I preferred this to some of those other options because it is a commercial product that has gone through rigorous testing.”
GW Pharmaceuticals’ product will be entering a complicated and controversial market—despite an increase in states that allow medical marijuana, the U.S. government continues to classify it as a controlled substance “with no medical use.” It shares this categorization with heroin and LSD. However, the approval of Epidiolex may open the door for a number of other marijuana-derived treatments that have the potential to drastically improve, and in some cases, save the lives of patients.
(Sources: The Associated Press; The U.S. Food and Drug Administration)
(Feature Image: The Associated Press)
Filed Under: Drug Discovery
