Man dies after French drug trial

A man who had already been pronounced brain dead after taking part in a drugs trial in France has died in hospital.

The exterior of the Biotrial laboratory in France

Source: AAP

A man has died in a French hospital after taking part in a drug trial for a painkiller based on a compound similar to cannabis.

The Rennes University Hospital announced the death in a statement on Sunday, but didn't identify the patient, who had already been brain dead.

He was among six male volunteers between 28 and 49 hospitalised last week after volunteering to take the experimental drug.

French health authorities have said three of the hospitalised volunteers face possible brain damage, and an investigation is underway into what French Health Minister Marisol Touraine called "an accident of exceptional gravity."
The trial, which began January 7, involved 90 healthy volunteers who were given the experimental drug in varying doses at different times.

The hospital said it has contacted the 84 other volunteers exposed to the new painkiller.

Ten of those volunteers underwent medical exams on Saturday but the hospital found no anomalies, the statement says. It said another five will have medical exams closer to their homes.

The drug, based on a natural brain compound similar to the active ingredient in marijuana, was given orally to healthy volunteers as part of a Phase 1 trial by Biotrial, a drug evaluation company based in Rennes, on behalf of the Portuguese pharmaceutical company Bial.

In addition to treating pain, the drug was intended to ease mood and anxiety troubles as well as motor problems linked to neurodegenerative illnesses by acting on the endocannabinoid system.

In this system, natural brain compounds act on specific receptors to exert their effects.

It's rare for volunteers to fall seriously ill during Phase 1 trials, which study safe usage, side effects and other measures on healthy volunteers, rather than drug effectiveness.


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2 min read
Published 18 January 2016 2:59am
Updated 18 January 2016 6:47am
Source: AAP


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