One suffered brain death and died on Sunday.
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The orally-active drug – BIA 10-2474 – was meant to treat mood and motor disorders associated with neurodegenerative disorders and anxiety and is a fatty acid amide hydrolase (FAAH) inhibitor.
The tests were carried out by the Rennes-based Biotrial company for the Portuguese pharmaceutical company Bial.
The National Agency of Drug Safety (MSNA) authorized the trial on June 26, 2015, it began soon thereafter on July 9, 2015 at Biotrial.
The trial by the Portuguese pharmaceutical company involved about 90 healthy participants who received the company’s experimental drug with different doses at different times.
The Rennes University Hospital in western France announced the death in a statement, but didn’t identify the patient, who had already been in a state of brain death.
As per a statement by the hospital, “We have contacted the 84 other volunteers exposed to the new painkiller”. Six men, aged 28 and 49, were selected to begin a higher dose of the therapy, which experts believe caused the potentially catastrophic and irreversible neurological reactions observed.
French health authorities have said three of the hospitalized volunteers face possible brain damage.
The incident is the worst of its kind ever to have taken place in France, which has launched three separate probes to determine whether the tragedy was caused by an error in the trial’s procedures or in the substance tested.
It was reported on Friday that the Paris prosecutor’s office has opened an investigation into the trial.
The drug reportedly acts on the endocannabinoid system in the brain – which is also part of the brain that processes chemicals from cannabis.
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“On my behalf and the behalf of Bial, I would like to express my deepest apologies to the family of the volunteer who died after participating in the Phase I trial of our experimental molecule”, he said. This phase of drug trials usually only measures the drug for safe use and side effects and not yet for their effectiveness.
