UK-based GW Pharmaceuticals made history by becoming the first company to get U.S. Food and Drug Administration (FDA) approval for their prescription cannabidiol (CBD) medicine—Epidiolex. While marijuana is still treated by federal law as an illicit Schedule 1 drug, the approval of Epidiolex may open doors for derivatives of cannabis to be approved for additional treatments.
Desperately Seeking Cures
In the last decade, the FDA has approved almost 90 drugs for neurological diseases. Unfortunately, none among them were deemed effective cures. However, for seizure sufferers, Epidiolex, a CBD-based liquid, has shown to be significantly effective in treating epileptic seizures.
Epilepsy, which affects approximately four percent of the U.S. population, is a neurological disease, caused by an abnormal response of the cerebral cortex to stimuli of various kinds. It is more frequent in children and adolescents until puberty, and may be caused by injuries of the brain, or by an alteration of the function of nerve cells.
Although seizures are the hallmark physiological response of epilepsy, the disease may also manifestat as a loss of consciousness. While the disease can affect the entire body, seizures are sometimes localized in one arm; the neurological spasms can also affect one side of the face or one side of the body.
Hurdles To Epidiolex
Although research studies have shown beneficial effects of medical marijuana, doctors are reluctant to prescribe it and insurers are unwilling to cover the costs. Federal law makes it difficult to conduct large-scale marijuana clinical trials. But as more states are approving marijuana for medical or recreational purposes, more research on marijuana-based derivatives may come to fruition.
For more cannabinoid-based medicines to be approved, study data is needed for efficacy and safety. “It’s vital for physicians to be sure these medicines are carefully formulated, and quality and quantity remain the same, month after month,” says Dr. Orrin Devinsky, of NYU Langone Epilepsy Center.
Thus far, placebo-controlled clinical trials on Epidiolex show promise; the drug reduced seizures by approximately 40 percent in patients with Lennox-Gastaut syndrome, a rare childhood epilepsy. Patients with Dravet syndrome, another rare form of epilepsy, have also successfully had reduced seizures with the drug. This is impressive because both diseases are highly resistant to existing anti-epileptic drugs.
Another marijuana-based drug produced by GW Pharmaceuticals, Sativex, has already been approved in several European markets. Sativex treats muscle spasms in multiple sclerosis patients. Sativex is an equal 50% mixture of CBD and THC, the former being the non-psychoactive component of the cannabis plant, while the latter is the psychoactive ingredient that makes users feel high. As of this writing Sativex is approved in the UK and 20 other countries.
In 2015, GW Pharmaceuticals began studies designed to evaluate the effect of Sativex on thousands of cancer pain patients. The worldwide acceptance of CBD and THC based medicines will help pave the way for clinical trials on a wide array of medical issues, and doctors have their eyes set on autism and chronic inflammatory diseases next.