First cannabis-derived drug authorised for France

January 9, 2014

France has for the first time approved prescription use of a drug derived from cannabis—a mouth spray used to treat multiple sclerosis (MS) symptoms, the government said Thursday.

The medicine, called Sativex, is already authorised in several European neighbours, but had remained off-limits in France due to a ban on any products derived from the marijuana plant.

The health ministry published a policy change last June, opening the door for medical use of the drug's active ingredients.

The first market authorisation was given on Wednesday by the National Agency for Drug Safety (ANSM), the ministry said.

Sativex, produced by the British firm GW Pharmaceuticals, has been approved for use in alleviating muscle stiffness and spasms from MS.

"The market authorisation is an interim step" before the drug becomes available from pharmacies, but on prescription only, said a ministry statement.

The spray's main active ingredients are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).

ANSM official Nathalie Richard said Sativex was not recommended for breastfeeding or pregnant women or people with a history of psychosis.

Medical cannabis use is already a reality in countries like the Netherlands, Spain, Italy, Germany and Britain, Canada, Australia and some American states.

In Canada, Sativex is also used to alleviate pain associated with cancer.

New York Governor Andrew Cuomo announced Wednesday he will authorise medical marijuana use, making his the 21st US state to do so.

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