United States approves Epidiolex, first marijuana-derived drug


While most hemp-derived CBD companies are rapidly growing their businesses without repercussion or worry, many cannabis CBD businesses are hesitant about selling products in states where marijuana is not yet legal. The agency has previously approved drugs made from synthetic versions of THC and other marijuana constituents.

It contains less than 0.1 percent of tetrahydrocannabinol (THC), the psychoactive component that makes people high.

It is estimated there are up to 18,500 patients with LGS, and 20,000 of Dravet Syndrome in the United states.

A GW Pharmaceuticals spokeswoman said the company would not immediately announce a price for the drug, which it expects to launch in the fall. 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.

"This hits home at the reality that the FDA can and will approve cannabinoid-based medications that meet the standards of quality, safety, and efficacy", Gover said. It also marks a landmark moment in the agency's advancement in considering cannabis for medical purposes. And like other drugs that treat epilepsy, Epidiolex will come with a special warning that use may be tied to a higher odds of depression, aggression and suicidal thoughts. Experts are hopeful that the approval will unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds.

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The drug is approved for use against Lennox-Gastaut syndrome and Dravet syndrome in patients two years of age and older, the FDA said.

For years, families of children with severe seizure issues have been turning to marijuana-based substances to find relief from debilitating episodes, often skirting the law to obtain what they said was their only effective treatment option. The British drugmaker studied the drug in more than 500 patients with hard-to-treat seizures, overcoming numerous legal hurdles to conducting research with cannabis. There are only a few pharmaceutical treatments for patients living with Lennox-Gastaut, no pharmaceutical options for those living with Dravet syndrome.

The FDA's green light on Epidiolex, coupled with the DEA's reclassification of CBD, could have big implications for the future of cannabis-based medicine.

An FDA advisory committee recommended approval of Epidiolex in April; it had until this week to make a decision on the recommendation. "As to whether this product provides them with the treatment they are looking for". The agency is expected to do so within 90 days.

"There is some research that indicates that CBD specifically could interact with other medications such as statins, and increases the amount of those medications in the blood", Chadi said. And the company plans to continue importing the medicine, bypassing onerous USA regulations on manufacturing restricted substances. The FDA's decision directly contradicts the decision by the Drug Enforcement Administration to keep the newly approved compound, cannabidiol, under the umbrella of marijuana as a Schedule I substance, since by definition drugs in that class have no medicinal benefit.