US FDA approves first ever marijuana-based drug

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While Sederberg may be right, the concerns expressed by those who have already been using CBD medically have validity.

FDA has approved, for the first time, a drug ingredient containing a purified drug substance derived from cannabis (Cannabis sativa) for the treatment of severe forms of epilepsy.

The drug's approval permits https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf its use in patients aged two years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment. "Lennox-Gastaut Syndrome is a devastating form of epilepsy, and despite now available FDA-approved medications and a poly-therapy approach to treatment, the majority of individuals with LGS will continue to have life-long, debilitating seizures, along with cognitive impairment and an abnormal brain waves on EEG (electroencephalogram)".

Gottlieb added that controlled clinical studies evaluating a drug's safety and efficacy in combination with a careful review through the FDA's drug approval process, is the most suitable way to introduce marijuana-based treatments to patients.

GW Pharma grows its own supply of cannabis in specialised glass houses in the United Kingdom to ensure uniformity in the genetic composition of the plants, which are then processed into a liquid solution of CBD.

"The FDA prepares and transmits, through the U.S. Department of Health and Human Services, a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the CSA". Schedule 1 drugs are deemed to have no medical value and present a high risk of abuse.

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GW expects to make Epidiolex available to appropriate patients by fall 2018.

The DEA did not immediately respond to Ars' request for comment. That decision is expected within 90 days.

"Today's announcement gives individuals with Lennox-Gastaut Syndrome and their families much-needed hope", says LGS Foundation executive director, Christina SanInocencio. In some cases, patients have moved to states that have legalized medical marijuana in order to have access to the drug. However, the legal status of these products is uncertain, as is their quality.

DEA spokesman Melvin Patterson said the agency has no plans to reschedule or deschedule marijuana, though there is a "discussion" about rescheduling CBD. Reportedly, this cannabis based medicine is formulated to treat epilepsy in children and is claimed to be the first of its kind to get merchandized in the USA pharmaceutical market.

While FDA is prepared to continue supporting scientific research focusing on marijuana-based products with medicinal uses, they will also be monitoring the market for CBD-related products making medical claims that are unproven.

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