Approval of first marijuana-based drug opens doors for people with epilepsy

28 June, 2018, 00:47 | Author: Jeffery Armstrong
  • Marissa Parsons who has Lennox Gastaut syndrome visits the Grand Canyon with her family in 2016

Epidiolex is based on cannabidiol, more commonly called CBD, rather than THC, which is the component associated with psychoactive effects.

The move marks several firsts.

The drug, named Epidiolex, received unanimous recommendation from an FDA advisory committee in April.

The future of medical marijuana is looking brighter after the federal government approved the nation's first marijuana-based prescription medicine this week.

In a call with reporters yesterday, the FDA's commissioner of food and drugs, Scott Gottlieb, MD, said "We remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims".

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"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", Gottlieb added.

The U.S. health regulator approved GW Pharmaceuticals Plc's epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the country and opening floodgates for more research into the medicinal properties of cannabis.

The drug, which will become available this fall, will hopefully be a wonderful option for parents of epilepsy patients who have, until now, had their hands tied when it comes to improving their kid's quality of life. In three clinical trials covering 516 patients with either form of epilepsy, Epidiolex plus other antiepileptic medications reduced the frequency of seizures.

The FDA said the action isn't an approval of overall marijuana use, even if it's meant to treat other illnesses, but pharmacists said the FDA's decision could lead to more marijuana-derived drugs.

The administration pointed out that unlike THC, a more well-known chemical component of marijuana, CBD doesn't cause intoxication.

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Dravet syndrome is a rare genetic condition that usually shows up in infants, starting with fever-related seizures and progressing to other, more severe seizure types.

It is a purified form of cannabidiol (CBD), one of the hundreds of molecules found in marijuana.

The GW Pharmaceuticals team said in a statement it was pleased to finally have such an important drug on the market to provide hope to two long and hard types of childhood-onset epilepsy. The FDA has sent warning letters to companies that hyped their drugs as cancer or Alzheimer's fighters.

Reclassification of CBD could set the stage for the approval of other cannabis-derived medications. For instance, a clinical trial is underway to test whether CBD can be an effective treatment for people with post-traumatic stress disorder and alcohol use disorder. 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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