Last week a Phase 1 drug trial was halted after six patients were left in serious condition. One man was left brain dead and subsequently died, while five others were hospitalized. The other men are now in stable condition, although three of which may have permanent neurological damage.
This trial was investigating a novel fatty acid amide hydrolase (FAAH) inhibitor, which targets the body’s endogenous cannabinoid system, mimicking a cannabis-like effect on pain relief. The Portuguese pharmaceutical company, Bial, was exploring the drug as a pain reliever for anxiety and motor disorders associated with Parkinson’s disease, and chronic pain in people with cancer and other conditions.
The trial was being conducted by Biotrial, a French contract-research organization, and involved 128 healthy volunteers between the ages of 18 and 55, 90 of which received different doses of the study drug. The six participants who fell ill were the first to receive repeat higher doses over the course of several days.
It is rare for volunteers to experience serious adverse events in Phase I trials. French prosecutors have launched a manslaughter investigation into this case, and Bial has stated they are working closely with the Health Authorities to understand the causes of this tragic situation.