Published: Wed, June 27, 2018
Medicine | By Daryl Nelson

FDA OKs First Drug Containing CBD

FDA OKs First Drug Containing CBD

For the first time, the FDA approved a drug derived from the marijuana plant, and it could help patients with rare forms of epilepsy.

The drug is the "first pharmaceutical formulation of highly-purified, plant-based cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs", according to a statement Monday from GW Pharmaceuticals, the UK-based biopharmaceutical company that makes Epidiolex.

GW Pharmaceuticals, the British company responsible for the drug, said now approved AEDs (anti-epileptic drugs) are not always effective in the majority of patients with Lennox-Gastaut Syndrome (LGS) and Dravet syndrome - severe forms of childhood-onset epilepsy. Last year, the FDA sent warning letters to a number of CBD manufacturers, demanding that they cease making "unproven" claims that their medicines can fight cancer. It also marks a landmark moment in the agency's advancement in considering cannabis for medical purposes.

"The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", Gottlieb said. Gover said the green light signifies that his company's recent efforts in developing more drugs from marijuana's compounds (also known as cannabinoids) finally have a concrete path forward.

Epidiolex would also be the first approved therapy for DS, treatments for which are now limited to a combination of seizure medication and drugs to prevent emergencies. That decision is expected within 90 days.

"Such a process ensures that any new therapies from marijuana and its constituents are safe, effective and manufactured to a high and consistent quality and most importantly, that these products have been proven safe and effective for patients", Gottlieb added.

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Epidiolex is also the first prescription created to treat children with Dravet syndrome, according to the FDA's announcement.

GW Pharmaceuticals has been working to change state drug schedules ahead of the FDA approval announcement. It is currently a Schedule 1 drug, along with heroin, because of abuse potential, but GW expects Epidiolex to have a less restrictive DEA scheduling because of studies showing minimal abuse potential and now an approved medical use. 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. "However, it remains to be seen whether physicians will be comfortable prescribing this new agent to those patients who may benefit from it, and whether it will be priced in a range that patients may afford".

"We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant", Armentano continued.

GW Pharma won't be able to launch the drug right away, however, because its active ingredient, CBD, needs to be rescheduled by the DEA.

The FDA is not required to follow the advisory panel's advice but usually does.

"And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition", he continued.

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