GW Pharmaceuticals has just completed and reported positive results for an oil derived from marijuana plants called Epidiolex. The oil's creators intend for it to become a medication capable of treating rare forms of epilepsy such as Lennox-Gastaut syndrome, which is notoriously difficult to treat.
What is Epidiolex?
Epidiolex is the marketable drug form of pharmaceutical-grade cannabidiol (CBD), an oil naturally occurring in marijuana plants. The extracted oil retains nearly immeasurable amounts of tetrahydrocannabinol (THC), the infamous substance that causes consumers of marijuana to experience an altered consciousness.
GW intends to formulate Epidiolex to include therapeutic amounts of CBD with a reasonable tolerability profile that will allow a wide range of epilepsy sufferers to attempt treatment with the marijuana-derived drug. Its most successful trials have shown potential as a method of mitigating orphan pediatric epilepsy syndromes. The FDA has granted Epidiolex the Orphan Drug Designation for severe infantile-onset, drug-resistant epilepsy syndromes.
How is Epidiolex Created?
GW Pharmaceuticals grows marijuana plants in specialized grow houses that produce plants which yield a large amount of CBD while minimizing THC. Growth conditions are regulated by a computer, which controls temperature, humidity, light, and photoperiod, among other minute processes.
Plants are harvested and oil is extracted on-site from the marijuana plants. The CBD-rich oil is then processed to remove any remaining THC and maximize CBD content.
Each step of the process, from growth to purification, is carefully quality-controlled and subject to the rigid Standard Operating Procedures (SOPs) outlined by GW Pharmaceuticals. GW also meets international Current Good Manufacturing Practice (CGMP) regulations, a set of rules to which all drug manufacturers must adhere. The FDA and other national regulatory agencies closely monitor actions within GW to ensure compliance with these standards and regulations.
What Can It Treat?
While researchers are currently exploring all possibilities of its medical use within the limits of the law, the active ingredient cannabidiol has shown efficacy in helping to treat a variety of conditions. The Journal of Clinical Investigation reported that CBD has shown potential as an anti-inflammatory agent and acne treatment. The National Institute of Health has also published information stating the effectiveness of CBD in arresting diabetes in mice.
However, the aim of GW Pharmaceuticals is to focus the treatment potential of Epidiolex toward treating rare forms of epilepsy. Its chief application thus far is use as an alternative treatment for Dravet and Lennox-Gastaut syndromes, though it may be capable of reducing the symptoms of other, rarer infantile-onset epilepsy syndromes.
About the results of the company's latest Phase 3 Epidiolex clinical trial, investigator Linda Laux, MD said:
"These data show that Epidiolex has the potential to provide a robust and clinically meaningful reduction in seizures in this highly treatment-resistant population together with an acceptable safety and tolerability profile, which is consistent with my previous clinical experience with Epidiolex."
GW will continue clinical trials and looks to submit the drug to the FDA in the first half of 2017, according to Justin Gover, GW’s Chief Executive Officer. While awaiting FDA submission and approval, researchers will continue to improve the formula to reduce side effects and maximize efficacy. As development continues, we could see Epidiolex and other medical marijuana treatments become available for epilepsy, diabetes, acne and other conditions.