United Kingdom -based GW Pharmaceuticals says the solution, taken by mouth, is made from a proprietary strain of cannabis created to maximize a therapeutic component while minimizing components that produce euphoria.
CBD acts on different parts of the nervous system compared with THC.
USA health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.
GW Pharmaceuticals' Epidiolex is pictured, June 23, 2017.
The medicinal acknowledgment of CBD should come as good news to marijuana startups eyeing the compound for consumer and medical consumption. In three clinical trials covering 516 patients with either form of epilepsy, Epidiolex plus other antiepileptic medications reduced the frequency of seizures. The trial lasted 14 weeks.
Shauna Garris, a pharmacist, pharmacy clinical specialist and adjunct assistant professor at the University of North Carolina's Eshelman School of Pharmacy, said the drug is effective and works somewhere between "fairly" and "very well". "Yet we were surprised at how robust the response was in this study", Dr. Anup Patel, a pediatric neurologist at Nationwide Children's Hospital in OH and one of the lead authors of the study, told ABC News. GW Pharma says about 6,000 to 10,000 have Dravet Syndrome. Researchers enrolled 120 children and young adults to compare Epidiolex to standard anti-epileptic treatment.
Proponents of medical marijuana have heralded the substance as the "answer to the opioid crisis" for relieving chronic pain with nonfatal side effects.
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Epidiolex is based on cannabidiol, more commonly called CBD, rather than THC, which is the component associated with psychoactive effects.
Some have said that they have no intention of switching to the new prescription CBD drug because the products they're using are helping their children. It may also have far-reaching implications for US marijuana policy.
She says 17 doctor-prescribed drugs didn't help her son. Until now, the Drug Enforcement Administration has classified CBD as a Schedule 1 substance.
A reclassification is expected within 90 days, according GW Pharmaceuticals.
What should parents be aware of now? What's more, the DEA will reportedly reschedule CBD in light of the FDA's decision, greatly loosening restrictions on research. "Nonetheless, these alternatives should not be regulated as options to replace the use and regulation of herbal cannabis - a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 30 states".
Treatments available for both disorders are far from ideal and some patients resort to buying "self-prescribed" CBD online or from unregulated vendor sites, Dr. Pavel Klein, founder of the Mid-Atlantic Epilepsy and Sleep Center, said. "These products haven't been tested for safety and effectiveness".