Dravet syndrome die before reaching adulthood, according to the National Institutes of Health.
CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. CBD oil has gained popularity with consumers as a remedy for a variety of other ailments. "Fast-track designation was granted for Dravet Syndrome and Orphan Drug designation was granted for both the Dravet Syndrome and Lennox-Gastaut Syndrome (LGS) indications".
At the CU Skaggs School of Pharmacy, there are now a few drugs being tested - one for seizures and the other for Parkinson's tremors that are both are derived from cannabis. What's more likely is that the DEA reschedules CBD, while leaving THC and marijuana itself as a Schedule 1 substance.
The most common side effects of Epidiolex include diarrhea, rash, insomnia, and infections.
Epidiolex will be marketed in the United States by GW's US subsidiary, Greenwich Biosciences. Schedule 1 drugs are deemed to have no medical value and present a high risk of abuse.
FDA's Gottlieb warned about the use of CBD products with "unproven medical claims". "And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition", said Gottlieb. Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.
"We are very pleased to see the approval of EPIDIOLEX® for Dravet and Lennox-Gastaut Syndromes, says Dravet Syndrome Foundation executive director Mary Anne Meskis". "This approval, however, means patients can be assured of getting a consistent dose of the drug because of the standards set by the FDA", says Dr. Hussain.
50 children in the United Kingdom have been given Epidiolex as a treatment as part of a large scale clinical trial that took in 1,500 kids worldwide.