US OKs marijuana-based prescription drug for seizures

Faith Castro
June 26, 2018

GW Pharmaceuticals, the British company responsible for the drug, said now approved AEDs (anti-epileptic drugs) are not always effective in the majority of patients with Lennox-Gastaut Syndrome (LGS) and Dravet syndrome - severe forms of childhood-onset epilepsy.

A new epilepsy medicine derived from cannabis could be in the hands of patients before any medical marijuana reaches the shelves in Ohio. It is currently a Schedule 1 drug, along with heroin, because of abuse potential, but GW expects Epidiolex to have a less restrictive DEA scheduling because of studies showing minimal abuse potential and now an approved medical use.

"This is an important medical advance", Gottlieb said.

A government-regulated version of the oil will ease some doubts about the amount of CBD in the product, which can vary based on its origin, said Dr. Elaine Wirrell, director of the Mayo Clinic's child epilepsy program.

"The FDA prepares and transmits... a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the [Controlled Substances Act]", the FDA stated, indicating that it will recommend that CBD be rescheduled but the act of shifting the substance's legality is ultimately in the DEA's hands. 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. Any drug containing cannabis from here on out will still need to clear plenty of hurdles before getting approval.

Although THC can induce paranoia, anxiety and hallucinations, CBD has the opposite effects and has been cited by scientists as a potential treatment for mental health issues.

That's because these kids did not experience as many side effects from the cannabidiol, which can include tiredness, decreased appetite, diarrhea and signs of possible liver damage, Devinsky explained.

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Epidiolex won't require a special certification to prescribe, Patel said, and it's likely physicians will prescribe it for off-label uses.

CBD oil is now sold online and in specialty shops across the USA, though its legal status remains murky.

Still, this approval comes as the White House is said to be reconsidering federal prohibition of marijuana and as more and more states approve it for recreational and medicinal use.

The FDA is not required to follow the advisory panel's advice but usually does. This treatment we have studied for the last five years.

GW Pharmaceuticals says it is not their intention to shut out other marijuana products and that they only want to make sure their medicine is accessible.

The FDA's Scott Gottlieb did the honors in the statement today, celebrating GW for the work they did, and warning anyone else against trying to market cannabis-related products with dubious support for their claims.

Prior to the FDA decision, a press officer for the DEA confirmed to Leafly that the FDA decision will prompt action from the DEA.

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