FDA Approves Cannabis Based Drug

28 June, 2018, 00:51 | Author: Cassandra Gardner
  • AP  File 2017		GW Pharmaceuticals’ Epidiolex a medicine made from the marijuana plant

The liquid is made from a compound in the marijuana plant called cannabidiol, a different chemical from tetrahydrocannabinol, or THC, which gets users high.

The U.S. Food and Drug Administration announced Monday, June 25, that it's approved a marijuana-derived drug for the first time.

The move marks several firsts.

The FDA approved the first drug with an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. "Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery".

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Elizabeth Thiele, director of the paediatric epilepsy programme at Massachusetts General Hospital, professor or neurology at Harvard Medical School and a lead investigator in the Epidiolex clinical programme, said: "LGS and Dravet syndrome are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy".

In a study involving children with Dravet syndrome, five percent became seizure free while taking the drug compared to none in the placebo arm, and patients also had a significantly greater median reduction in convulsive seizures (39 percent) compared to placebo (13 percent).

GW Pharmaceuticals chief executive, Justin Gover said that the medicine is a prescription drug shown to reduce seizures in clinical trials.

Epidiolex is reportedly an oral solution meant to treat seizures that are known to be associated with two particular types of epilepsy, the Lennox-Gastaut syndrome, and Dravet syndrome, for children 2 years old and above.

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CBD is one of more than 80 compounds found in the marijuana plant, according to a statement from Scott Gottlieb, MD, FDA commissioner.

LGA and Dravet syndrome develop in childhood and are rare, severe forms of epilepsy that are notoriously hard to treat. The medication contains canabidiol (CBD), a component of cannabis that doesn't have THC. But Garris highlighted that numerous side effects occur when it is taken with other medications, which she said is a concern because most patients are on other medications. Many clinical trials have been conducted or are now underway testing CBD's ability to treat a variety of ailments. However, Schultz says his company plans to create more CBD medications.

Despite today's approval, the FDA acknowledged in a statement that the cannabidinoid CBD still remains classified at this time as a schedule I controlled substance, and that the agency is "prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims". It's being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits.

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