The French health ministry said on Friday that six volunteers taking part in a drug trial held by an unnamed pharmaceutical company were sent to the hospital, leaving one patient in a coma and the remainder critically ill.
The initial statement released by the French health ministry didn’t specify what the drug was or which company sponsored the trial, but The Guardian, in conjunction with Agence-France Press, reported that it was a Phase 1 clinical trial for an oral painkiller containing cannabinoids, for a trial run by a firm called Biotrial.
Biotrial is a laboratory based in Rennes, France. The company posted an update on their website acknowledging it had held a study for a sponsor in which trial participants experienced adverse events. The trial was “conducted in full compliance with the international regulations and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital,” according to the update.
Health Minister Marisol Touraine said all six volunteers were healthy before they took part in the study, which tested the “safety, tolerability, pharmacological profiles of this molecule,” according to her statement.
All trials for this drug have been suspended. Touraine held a press conference on Friday where she said Biotrial conducted the study on behalf of Portugal-based Bial, according to Reuters.
The drug being tested didn’t contain cannabis or any substance that was derived from cannabis either.
The Associated Press (AP) reported on Sunday that one of the participants had died. The Renees University hospital where the volunteers were being treated didn’t identify the patient in its official statement, but the others still remain hospitalzed.
Also, the AP writes that the hospital said it has contacted, “the 84 other volunteers exposed to the new painkiller. Ten of those volunteers underwent medical exams Saturday, but the hospital found no anomalies, the statement says. It said another five will have medical exams closer to their homes, but didn’t say whether the others are being monitored or tested.”
Filed Under: Drug Discovery