November 13, 2018

Cannabis Medicine To Treat Epilepsy Officially Approved By FDA

27 June 2018, 02:06 | Rodolfo Wallace

Cannabis Medicine To Treat Epilepsy Officially Approved By FDA

Cannabis Medicine To Treat Epilepsy Officially Approved By FDA

The FDA took pains to specify that clearing Epidiolex for use is not an approval of marijuana or any of its components.

This reschedule should make it easier for researchers to study CBD for its potential health benefits.

The Drug Enforcement Administration (DEA) classifies marijuana or cannabis as a Schedule 1 substance - which means there is "no now accepted medical use and a high potential for abuse". In three clinical trials covering 516 patients with either form of epilepsy, Epidiolex plus other antiepileptic medications reduced the frequency of seizures. The drug, Epidiolex, is meant to treat seizures resulting from Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy.

Gottlieb emphasized that the approval of Epidiolex does not have any implications for the approval of marijuana as a medicine more broadly, but the move is still widely seen by the industry as a significant step towards acceptance of the cannabis plant. Rescheduling cannabidiol paves the way for other advanced cannabinoid formulations, like the ones now being researched and developed by scientists on staff at my Colorado-based cannabinoid science business, ebbu. GW won't be able to market Epidiolex until the DEA reclassifies CBD.

Most patients with LGS and DS require multiple seizure medications and the majority are resistant to now approved anti-epileptic drugs.

The FDA cites a number of side effects associated with Epidiolex that may give some patients pause, however, including the potential for increased liver enzymes, weakness, poor sleep quality, and diarrhea, among others.

On a call with reporters on Monday, FDA Commissioner Scott Gottlieb, M.D., cautioned that Epidiolex's green light is not an approval for marijuana but an approval for "one specific CBD medication for a specific use" based on well-controlled clinical trials.

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The drug is made from purified cannabidiol, or CBD, a compound found in the cannabis plant.

Patients with Lennox-Gastaut and Dravet syndromes, which typically emerge in the first few years of life, can suffer from debilitating and recurrent seizures, sometimes dozens a day.

The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle.

Still, Jackson is glad that her family's experience could now provide new treatment options for other childhood seizure sufferers. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy. Almost all patients with these conditions continue to have daily seizures-some having multiple per day-despite the use of legally available drugs.

For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market. Shinnar said he will welcome approval of a medicine that had undergone stringent FDA review for safety and effectiveness.

"And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition", he continued. The DEA's decision is expected to be made within 90 days.

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