The outstanding results of a CBD-based oil tested on 120 epileptic children could spur the federal government into approving a marijuana-based product for legal consumption.
Advisors to the federal Food and Drug Administration (FDA) agency have come out in strong support of a cannabidiol medication, named Epidiolex, and have recommended that the federal government give approval for the drug which treats severe and rare forms of epilepsy. If the green light is given, the CBD oil will be used exclusively for the treatment of children two years and older who suffer from Lennox-Gastaut or Dravet syndromes.
The FDA has indicated that they will give Epidiolex the green light and in a statement to their advisors said the studies had provided substantial evidence of the efficacy of the drug to treat children with these rare and severe epileptic syndromes.
Evidence From Parents and Their Epileptic Children
The FDA also heard evidence from the parents and epileptic children. One mother said her daughter had suffered thousands of epileptic episodes by the time that she was 14 years of age. No prescribed medications had been effective. Another 16-year-old boy said he had been able to visit South Africa on a school field trip – an opportunity that would never before have been thinkable without the use of the drug to curb his seizures.
The president and CEO of the Epilepsy Foundation, Philip Gattone, says Epidiolex spells hope for children wracked with disabling and intractable seizures and who face the constant threat of serious injury or even death. Epidiolex has been thoroughly tested by a British pharmaceutical company and is manufactured in syrup form.
Children Can Lead Normal Lives
The director of the NYU Langone Epilepsy Center, Dr Orrin Devinsky, explained that the drug tested on children was derived from marijuana plants and was 99 percent pure. Dr Devinsky went on to say that children previously bound to wheelchairs, spending most of their lives either asleep of suffering seizures, were now “running around, kicking soccer balls” and attending school since being treated with the CBD oil.
The study examined the after-effects of Epidiolex administered to 120 children diagnosed with Dravet syndrome and recorded a marked decrease in their number of seizures in comparison to children who were given a placebo. The medical profession is now also interested in using the CBD oil to treat other illnesses such as autism, auto-immune and other inflammatory disorders.
A Breakthrough Drug
Describing Epidiolex as a “breakthrough drug for an awful disease”, Dr John Mendelson of Maryland’s Friends Research Institute in Baltimore was one of the 13 members on the FDA panel who voted unanimously in favor of the cannabis-based medication. The FDA is expected to make a final decision towards the end of June. If the go-ahead is given it will open the door for doctors to prescribe the drug for other illnesses such as autism, auto-immune and other inflammatory disorders. It could also herald more research by pharmaceutical companies into a wider field of marijuana-based medications.
CBD is but one of more than 100 chemical compounds contained in marijuana and does not cause patients to experience the “high” associated with weed that contains the THC element.
If approved, Epidiolex will cost a pretty penny with Wall Street analysts predicting the cost at in excess of $25,000 annually.
The drug has been found to cause side-effects such as diarrhea, fatigue, nausea and sleeping disorders but doctors and parents believe this to be a small price to pay to help children suffering uncontrollable seizures.
The CBD cannabidiol medication has changed the lives of many children tested with the marijuana-based drug. Previously confined to wheelchairs and spending most of their lives either sleeping or suffering seizures, these children today attend school and run around the playfield. In fact, Epidiolex has been described as a “breakthrough drug for an awful disease”, a sentiment shared by many parents and members of the medical profession closely associated with the ravages inflicted by these severe and rare forms of epilepsy.
The FDA has given strong indications that it will approve the use of this medication by no later than the end of June – a true breakthrough for patients and the growing acceptance of marijuana by the medical profession as a plant containing many safe and healing compounds.