US approves Epidiolex, first marijuana-derived drug

US approves Epidiolex, first marijuana-derived drug

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.

In the meantime, it is possible that once on the market, Epidiolex could be prescribed for conditions other than the ones it's approved for.

Some experts believe the anticipated approval will likely open the floodgates for product demand of other CBD products, and place further pressure on the FDA to move it along and approve other CBD-based medications. The family moved to Colorado in 2014 to take advantage of that state's more advanced medicinal marijuana program.

Physicians say it's important to have a consistent, government-regulated version.

The drug's approval permits its use in patients aged two years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment. As well, CBD remains in a legal grey area, making it hard for patients outside of legal states to acquire.

Cannabidiol is one of more than 80 active cannabinoid chemicals, yet unlike tetrahydrocannabinol, or THC, it does not produce a high.


FDA's Gottlieb warned about the use of CBD products with "unproven medical claims". The FDA has previously sent warning letters to companies that hyped their products as cancer or Alzheimer's fighters. "Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases". Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy.

That's according to Steve Fox, the director of VS Strategies, which was retained by GW Pharmaceuticals to assist with lobbying and public relations efforts. The company has not yet set a price for the drug and said it would work with insurance providers to ensure the medicine would be covered under health plans. But Garris highlighted that numerous side effects occur when it is taken with other medications, which she said is a concern because most patients are on other medications.

A mother feeds her epileptic son, whom she treats with medical marijuana, in Siedlce, Poland, in October 2017.

First, the FDA must confer with the Drug Enforcement Administration to decide when to "reschedule" cannabidiol, better known as CBD, Devinsky said.

"For a maligned substance like cannabis, I think the vindication tour will ultimately be years long", said Ricardo Baca, a former marijuana editor at the Denver Post, and the founder of Grasslands, a cannabis PR agency.

Prior to the FDA decision, a press officer for the DEA confirmed to Leafly that the FDA decision will prompt action from the DEA. It comes from a proprietary strain of cannabis grown by GW that has been bred to have high levels of CBD and low levels of THC, the component that does make people high.

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