Medical milestone: USA approves first marijuana-based drug, Epidiolex for seizures

Medical milestone: USA approves first marijuana-based drug, Epidiolex for seizures

Medical milestone: USA approves first marijuana-based drug, Epidiolex for seizures

As of yesterday's approval from the Food and Drug Administration, the DEA has 90 days to put the drug's active ingredient, CBD, in a distinct category - separate from marijuana - so that doctors can prescribe it. The conditions typically begin in childhood, with frequent or prolonged seizures, and patients have a high risk of death from seizure-related causes and infections. This would be historic as CBD would no longer be listed, alongside the marijuana plant itself, as a Schedule I drug with "no accepted medical use". In three clinical trials covering 516 patients with either form of epilepsy, Epidiolex plus other antiepileptic medications reduced the frequency of seizures. In a statement released today, FDA notes that it "has taken recent actions against companies distributing unapproved CBD products". The FDA approved it for use in patients aged two and older who suffer from rare and severe forms of epilepsies known as Lennox-Gastaut syndrome and Dravet syndrome, which can develop early in childhood. Cannabis-derived CBD products are available where recreational marijuana is sold, though CBD derived from industrial hemp faces fewer regulations and is even stocked by some grocery stores. But thanks to a cannabis extract dubbed Charlotte's Web, Zaki's seizures all but stopped entirely.

The FDA's green light on Epidiolex, coupled with the DEA's reclassification of CBD, could have big implications for the future of cannabis-based medicine.

Side effects included sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor quality sleep and infections.

One key takeaway is that other drugs made with CBD now have a clearer path forward for federal approval.

The goal is have it available in pharmacies by the end of the year, said Orrin Devinsky, a pediatric neurologist and director of the New York University-Langone and Saint Barnabas Comprehensive Epilepsy Center in Livingston, who co-authored the research.

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While there was initially some confusion about whether the Drug Enforcement Administration might block the sale of Epidiolex, given cannabis' status as a Schedule I substance, Epidiolex manufacturer GW Pharmaceuticals doesn't believe that will be the case.

In April, an advisory committee unanimously recommended approval of the drug for the two types of epilepsy. But it's not quite medical marijuana. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy. The company is also looking beyond CBD at uses for marijuana compounds that range from neurological conditions to diseases like multiple sclerosis and cancer to other issues like pain.

For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market.

Epidiolex is under review in Europe as well, and GW expects a decision from the European Medicines Agency in the first quarter of next year.

The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education.

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