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Epilepsy patients in UNMC trial with marijuana-derived drug have seen improvement in seizures

September 20, 2018

LINCOLN — Most patients with severe epilepsy who’ve been taking a marijuana-derived drug through the University of Nebraska Medical Center continue to see improvement in their seizures.

A majority of the 23 patients who’ve remained in a two-year clinical trial have experienced fewer or less-severe seizures while taking purified cannabidiol, or CBD oil, a UNMC official recently reported to the Nebraska Legislature. The drug is extracted from a compound of the plant that doesn’t produce a psychoactive high.

In June, the U.S. Food and Drug Administration gave approval to GW Pharmaceuticals to market the drug under the brand name Epidiolex. The company is awaiting regulatory action by the Drug Enforcement Administration before it can begin selling the medicine.

GW Pharmaceuticals has supplied the medication to UNMC and other U.S. research centers to run clinical trials under special permission of the government, given marijuana’s federal status as an illegal drug.

In the meantime, about two dozen Nebraskans with forms of epilepsy that don’t respond to other treatments have been participating in the trial. The Nebraska Legislature allowed the scientific trial at the same time it turned away another bill to provide broader legalization of medical marijuana.

The recent report by Christopher Kratochvil, UNMC’s associate vice chancellor for clinical research, gave just a broad overview of trial results. Details about the number of patients who’ve seen benefits and the extent of their improvement will be complied and released in another couple of months.

In addition to significantly fewer and shorter seizures, some patients have experienced improved cognitive function and a better quality of life, Kratochvil said.

Eleven of the participants are under age 19. The patients who saw the greatest improvement suffer from two of the hardest-to-treat forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, Kratochvil said. People with the potentially fatal disorders can experience many severe seizures every day.

Four patients withdrew from the trial because of bad side effects or no improvement.

The drug will cost an estimated $32,000 annually. A company official told Business Insider last month that the price will keep the medication’s price in line with other epilepsy treatments.

Once the drug is commercially available, UNMC’s ability to get more at no cost will be limited, Kratochvil said. The medical center is in discussions with the company about continuing to receive the drug for study participants who can’t afford it or can’t get insurance coverage.

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