FDA grants first approval of a cannabis-derived medicine

Epidiolex, a cannabis-derived medicine, has been approved by the US Food and Drug Administration for the treatment of Lennox-Gastaut and Dravet syndromes for patients aged two years and older.

A laboratory analysis of GW Pharmaceuticals' cannabis samples

A cannabis-derived medicine has been approved for the first time by the US Food and Drug Administration (FDA).

The approval was granted to Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals, for Epidiolex, an oral solution of purified cannabidiol (CBD). The medicine is now approved in the United States for treatment of seizures caused by to Lennox-Gastaut and Dravet syndromes, which are both severe forms of epilepsy. The medicine may only be used in patients aged two years or older.

The decision follows a unanimous vote in favour of the approval by the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.

FDA commissioner, Scott Gottlieb, welcomed the news as an “important medical advance”, and said that Epidiolex “provides new options for patients.” But he emphasised that this decision did not represent an overarching approval of cannabis use.

The FDA issued a statement at the same time as approving Epidiolex, emphasising the importance of conducting proper research to prove safe and effective uses of cannabis and its components.

“This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition,” said Gottlieb. “Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery.”

The administration supports research into therapeutic use of cannabis and its components, Gottlieb said, including recommending the approval of several hundred research protocol licenses for research into cannabis or components isolated from cannabis.

“Research to demonstrate that marijuana or its components could be safe and effective in the treatment of medical disorders should be held to the same standard as other drug compounds,” he said.

Although legal to possess in some US states, cannabis is currently listed under Schedule 1 of the US federal government’s Controlled Substances Act, which is reserved for drugs that are considered to have “no currently accepted medical use and a high potential for abuse”.

The FDA approval of Epidiolex comes less than a week after Sajid Javid, the UK home secretary, announced that the government would consider whether medical cannabis ought to be rescheduled from Schedule 1 in the UK. The government also announced that an expert panel of clinicians, led by Sally Davies, England’s chief medical officer, would be set up to advise the government on individual applications for cannabis prescriptions.

The Royal Pharmaceutical Society has written to the Home Office in support of rescheduling, saying that “moving cannabis to Schedule 2 … would give pharmaceutical scientists greater freedom to research its potential medicinal uses and to carry out clinical trials.” Javid has said that if the review identifies significant medical benefits, then he intends to reschedule cannabis.

In the UK, the cannabis-derived medicine Sativex — also developed by GW Pharmaceuticals — has been licensed since 2010 for the treatment of spasticity in multiple sclerosis.

Last updated
The Pharmaceutical Journal, PJ, July 2018, Vol 301, No 7915;301(7915):DOI:10.1211/PJ.2018.20205071

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