The FDA May Approve Its First Cannabis-Based Drug This Week

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The FDA May Approve Its First Cannabis-Based Drug This Week

According to Dr. Angel Hernandez, of the Helen DeVos Children's Hospital in Grand Rapids, Mich., these results prove that pharmaceutical-grade CBD helps suppress seizures and "increases our options to treat many of these patients with very, very difficult-to-control epilepsies".

Gottlieb noted that the action was "not an approval of marijuana or all of its components" but rather of one specific CBD medication for a particular use. 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".

"Compared to other drugs used to treat epilepsy, I think Epidiolex, which is 99-percent pure cannabidiol, has a better side-effect profile than numerous available drugs", Devinsky said.

Once the DEA gets the FDA recommendation for how CBD should be scheduled, it has 90 days to decide.

Epidiolex is a twice-daily oral solution which doctors can prescribe to treat seizures related to Lennox-Gastaut syndrome and Dravet syndrome, two rare and severe forms of epilepsy.

Many companies sell cannabis-based treatments, touting them as cancer cures, pain relievers and anxiety medicines. However, the FDA has found that Epidiolex, when combined with other medications for epilepsy, does reduce seizures.

Most patients with LGS and DS require multiple seizure medications and the majority are resistant to now approved anti-epileptic drugs.

The FDA said Monday that the drug doesn't cause the high that comes from the chemical tetrahydrocannabinol, or THC, which is the main psychoactive component of marijuana.

"This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies", wrote FDA Commission Scott Gottlieb, M.D, in a statement.

"We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant", Armentano continued.

Epidiolex was approved for patients age 2 and older who suffer from Lennox-Gastaut and Dravet syndromes.

"There's a drug route and a pharmaceutical route and there's a dietary supplement route and we need to have both of those options available", said Jackson.

A mother feeds her epileptic son, whom she treats with medical marijuana, in Siedlce, Poland, in October 2017. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy.

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. "I really don't think it's going to affect us much". No clinical trials have proved that CBD can treat specific diseases.

Epidiolex was recommended for approval by an advisory committee in April, and the agency had until this week to make a decision.

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

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