First FDA Approved Cannabis-Based Drug Available for Prescription

Desiree Burns
November 4, 2018

The only licensed cannabis-derived medication is Sativex, which is used in the treatment of spasticity from MS. Epidiolex, which is FDA-approved in the USA, is in the process of becoming licensed.

Epidiolex, manufactured by United Kingdom -based GW Pharmaceuticals, is a formulation of "highly purified, plant-derived cannabidiol", or CBD, which does not produce the high associated with marijuana and is meant to treat seizures associated Lennox-Gastaut syndrome or Dravet syndrome, two of the most difficult-to-treat forms of childhood-onset epilepsy.

"Our community has long desired a medication specifically approved for the treatment of seizures associated with Dravet syndrome, and the availability of Epidiolex is an important milestone for patients and caregivers whose lives are significantly impacted by this catastrophic, lifelong form of epilepsy", said Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation. The panel voted 21-2 against the drug, saying the data did not support a favorable benefit-risk profile, the article reported.

That's in line with the FDA, U.S. Department of Justice and Drug Enforcement Administration, which already OK'd Epidiolex as a federal Schedule V substance, allowing it to be prescribed.

The EPIDIOLEX clinical development program included three randomized, controlled Phase 3 clinical trials and an open-label extension study. On average, it was able to reduce convulsive seizures by 25-28%.

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"There are some people who had dramatic improvements". "So I think it's very important to recognize ... that it clearly is effective, and this was statistically significant in all three of the large studies that we did, but by the same token, the effect was modest". "So it's not a miracle drug".

The drug was developed by GW Pharmaceuticals and will be marketed in the USA by its subsidiary, Greenwich Biosciences. She has not used Epidiolex in her own clinical practice and was not involved in the development of the drug but said she's not sure it will live up to "all of the hype" that has surrounded it.

"Drugs derived from marijuana also are eligible for several programs that are meant to facilitate and expedite development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions", Gottlieb said. According to the US Department of Health and Human Services, this is both legal and common; one in five of all medications prescribed is for off-label use.

It's not quite clear what the future ramifications will be from Epidiolex's success, but many other companies are exploring creating medications that use CBD. "The company expects that the drug will be covered by most insurance plans".

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