GW, CBD, And The FDA

By Benjie Cooper

IG: @nuglifenews

YouTube: Lucid’s Vlog

In 1998, British entrepreneurs Dr. Geoffrey Guy and Dr. Brian Whittle founded the cannabis-based firm, GW Pharmaceuticals with the goal of reintroducing the world to cannabinoid-based medicines and positively impacting the lives of people who deal with severe conditions on a daily basis. After obtaining a medical and scientific research cultivation license from the United Kingdom Home Office and the Medicines and Healthcare products Regulatory Agency (MHRA), GW developed a THC/CBD oral mucosal spray known as Sativex (nabiximols) for patients suffering from a variety of painful symptoms including neuropathic pain and spasticity.

In 2007, GW began pre-clinical research on the use of cannabidiol (CBD) by patients who have epilepsy. When they discovered that CBD exhibited significant anti-epileptic and anticonvulsant properties, they began focusing their efforts on Dravet Syndrome and Lennox-Gastaut Syndrome (LGS).

An orphan drug is a pharmaceutical agent that has been created to target a particular, rare medical condition, also sometimes referred to as an orphan disease. Dravet Syndrome and LGS are both listed as orphan diseases by the FDA, and in 2013, it granted GW Pharmaceuticals a Fast Track designation to develop a treatment for both conditions as well as Neonatal Hypoxic-Ischemic Encephalopathy (NHIE). NHIE is a neurological dysfunction in newborns where there is a lack of oxygen flow to the brain, sometimes causing permanent damage to it and other vital organs.

Currently, GW is in Phase 3 of the development of a liquid form of pure cannabidiol called Epidiolex, which the company derives from actual cannabis as opposed to synthesized sources from which other cannabinoid-based pharmaceuticals originate such as Marinol (dronabinol).

Children experiencing early-onset, drug-resistant epileptic conditions are the Epidiolex’s target recipients. Phase 3 of trials involving Epidiolex in children with Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS) are ongoing, and GW has already submitted clinical trial results to the FDA. The pharmaceutical firm is currently preparing their production facility for an official inspection by the Administration in early 2018. Following meetings with regulators, GW plans to take steps to obtain approval for the release of Epidiolex in Europe.

If the Food and Drug Administration is satisfied with GW’s clinical test results and gives its approval, Epidiolex could be available to patients sometime in 2018. The FDA’s stamp of approval on a liquid form of CBD means that people suffering from severe, drug-resistant epileptic conditions across the country might finally have widespread access to a medicine that has demonstrated a tendency to work when nothing else will. It’s the reason that families who live in states and countries where cannabis is illegal will risk much and go to great lengths to obtain the potent cannabinoid in hopes of providing relief for their epileptic children.

Despite saber-rattling from any officials, medical cannabis is returning to the United States, and Epidiolex is poised to be one of the next big breaks in the Federal wall of prohibition. FDA approval of a pure CBD product means that licensed doctors will, at last, be able to prescribe cannabidiol instead of just recommending it. The product will be available at a pharmacy instead of just at a dispensary. Medical cannabis is coming back but with the powerful benefits of modern technology and extensive research tools. GW Pharmaceuticals is proactively making use of those tools with the hopes of bringing relief and healing to epileptic children around the world.