FDA Approves Cannabis-Based Medicine for Seizures

Jun 27, 2018, 02:06
FDA Approves Cannabis-Based Medicine for Seizures

More importantly, a DEA representative recently affirmed that outlook, telling Leafly reporter Ben Adlin that if Epidiolex is approved, the DEA will "absolutely" reschedule CBD.

In a statement accompanying Monday's approval announcement, the FDA hastened to note that it's not signing off on the safety or medical utility of marijuana in general ― just this one compound and only for this limited use. Under the Controlled Substances Act, marijuana is a Schedule I drug, meaning it has a high potential for abuse and no recognized medical objective (heroin, LSD, and ecstasy are also Schedule I drugs).

Epidiolex, manufactured by GW Pharmaceuticals, is meant to treat seizures associated with two rare and severe forms of epilepsy. Carreno says that once the drug is descheduled, CBD manufacturers must register with the DEA-and that will make all the difference to the industry in the U.S.

"Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others", the FDA said.

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. In clinical trials, patients administered Epidiolex, on average, obtained a 40 percent reduction in seizure frequency.

Before GW can market Epidiolex, though, the Drug Enforcement Administration will have to reclassify CBD, which in this case, because it comes from marijuana, is considered a Schedule I drug, meaning it has no medical value and a high risk of abuse.

Fox hailed Monday's FDA action as a win for the broader medical marijuana community, in that it will facilitate more clinical research into the drug's medical benefits.

Epidiolex, made by British biopharma company GW Pharmaceuticals, uses purified cannabidiol (CBD), which is one of more than 80 active compounds in the cannabis plant.

The company has not said how much the drug will cost, but Wall Street analysts have predicted it could cost $25,000 per year. "In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition".

For medical marijuana advocates, it's a clear vindication of a fundamental premise of a decadeslong movement: that cannabis can have legitimate medical applications and it isn't the bogeyman that the federal government has long made it out to be.

There have been several national news stories about parents exploring the treatment and it's worked.

Gover said the approval signals "validation of the science of cannabinoid medication". Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy. GW Pharmaceuticals grows the plants in the United Kingdom.

Epidiolex is under review in Europe as well, and GW expects a decision from the European Medicines Agency in the first quarter of next year.

FDA approval of Epidiolex could open the door to cannabis-based treatments for a number of other conditions.

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