First Cannabis-based Medicine Gets FDA Approval
Thursday, the UK company, GW Pharmaceuticals made history by becoming the first company to get FDA approval for their prescription cannabidiol medicine. While the FDA is opposed to smoking marijuana to treat an array of chronic conditions, this move opens doors to derivatives of cannabis for additional treatments.
Desperately Seeking Cures
In the last decade, The U.S. Food and Drug Administration has approved almost 90 drugs for Neurology. None among them were cures, and for many, none of those promising remedies were meaningfully effective, but researchers say this new CBD-based liquid, Epidiolex, is significantly effective in treating seizures.
Epilepsy, a neurological disease, is a disease of the nervous system, due to 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. It’s characterized by sudden seizures, and while it can affect the entire body, these manifestations are usually a loss of consciousness and by sensory, psychic or motor alterations, are mostly localized to an arm, half-face or half-body. Nearly four percent of the U.S. population suffer from epilepsy.
But There Are Hurdles
Although there are always indications of beneficial effects of marijuana, doctors are reluctant to prescribe it and insurers are unwilling to cover the costs. This is unlikely to change until clinical evidence of cannabis efficacy and safety is in place. Prohibition laws have made it difficult to conduct large-scale marijuana clinical trials in the past, but it’s becoming easier to research cannabis now that pro-pot laws are passed.
In order to move forward, and have more cannabidiol-based medicines approved, study data is needed to prove their 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.
GW Pharmaceuticals has already been approved in several European markets for the THC-based drug Sativex, which treats muscle spasms in multiple sclerosis patients. This was their first flagship product which uses a 50-50 mix of CBD and THC, and approved by the UK and 20 other countries. In placebo-controlled clinical trials, Epidiolex 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 reduced seizures. This is impressive because both diseases are highly resistant to existing anti-epileptic drugs.
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.
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