Wednesday, 20 February, 2019

FDA Approves Medicine Containing Cannabis for the First Time

Melissa Porter | 26 June, 2018, 09:23

As a result, Epidiolex's launch remains at the discretion of the DEA which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, which would allow GW to begin selling it. United Kingdom -based GW Pharmaceuticals says the solution, taken by mouth, is made from a proprietary strain of cannabis created to maximize a therapeutic component while minimizing components that produce euphoria.

The FDA previously cleared medications containing synthetic versions of THC for nausea for patients getting chemotherapy and for other uses, but it had not approved any drug derived from the plant itself. Patel said the drug trials generated good information about safety and side effects of CBD use, and the FDA approval opens doors for more research on the benefits and effectiveness of CBD on other conditions.

The twice-daily oral solution is approved for use in patients 2 and older to treat two types of epileptic syndromes: Dravet syndrome, a rare genetic dysfunction of the brain that begins in the first year of life, and Lennox-Gastaut syndrome, a form of epilepsy with multiple types of seizures that begin in early childhood, usually between 3 and 5. FDA officials also said the drug doesn't appear to have abuse potential, citing minimal reports of euphoria in patients who took the drug in clinical studies. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD.

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.

A flowering marijuana plant.

Vivian's parents, Brian and Meghan Wilson, elevated the shortcomings of the state's medicinal marijuana program and helped pass a law that led to the availability of a wide range of strains.

"In the world of Dravet, there is always the fear of "running out of options" and now, as a community, we have one more option which gives families more hope and peace of mind", she added.

Several states have legalized CBD oil specifically for the treatment of intractable epilepsy or seizure disorders. Carreno says that a leader drug like Epidiolex often paves the way for other less expensive-and untested-CBD products. "Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases". Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions. A prescription drug provides a workaround to this issue.

Jackson's group estimates the typical family using CBD to treat childhood epilepsy spends about $1,800 per year on the substance.

Across the board, the drug was shown to be effective in cutting the frequency of seizures.

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

The European Medical Society is also considering approval of Epidiolex and is expected to announce a decision in the first quarter of next year, according to Gover.