Ph I trial of Bial pain drug sees one volunteer die

In a serious safety failure during a Phase I trial of a pain drug under development by Bial Portela, Portugal’s largest drugmaker, of the six healthy volunteers taking part, all were taken to hospital, with one in intensive care and described as brain-dead, who subsequently died.

The French Agency for the Safety of Health Products, the country’s drug regulator, authorized the trial on June 26, and it began on July 9 under the auspices of contract research group Biotrial at the University Hospital of Rennes, France.

Several Bial representatives are currently at the site to monitor the situation with the research center and the hospital, ensuring the necessary cooperation with these entities, as well as with the relevant authorities, according to the drugmaker.