A total of 128 volunteers took part in a clinical drug trial to test a painkiller by Bial, a Portuguese pharmaceutical company. The drug was intended to treat anxiety and motor disorders by working on the body’s endogenous cannabinoid system, which deals with pain. The trial was carried out by the Biotrial clinic in Rennes, France, a 150-bed research unit. Reports early on said that the drug was related to cannabis, but French Health Minister Marisol Touraine stated it does not contain cannabis or cannabis extracts.
The drug in question, code named BIA 10-2474, is an inhibitor of an enzyme called fatty acid amide hydrolase, or FAAH. The theory is that a drug blocking FAAH would allow naturally occurring anandamide (an endocannabinoid) to accumulate and act on cannabinoid receptors in a manner that wouldn’t manifest the psychoactive effects of cannabis.
The drug test subjects were between the ages of 18 to 55 and considered healthy. Ninety people were given different level dosages of the drug and the rest received the placebo. The Phase 1 test began on January 7, 2016. A Phase 1 drug trial is the first time an experimental drug is given to humans after a series of exhaustive laboratory and animal studies.
It appears that important details on the drug in question, including in-vitro and animal studies, are lacking. At the time of this news release, PubMed lists no publications of any type from Bial on any FAAH inhibitor.
All trials have now been suspended and volunteers recalled after the French healthy ministry confirmed that six male patients aged 28 to 49 had been healthy until taking the oral medication. One fell ill and the other five followed soon after to the hospital.
Pierre-Gilles Edan, head of the neurology department of a hospital in Rennes, stated that, “one man is brain dead, three others are suffering a handicap that could be irreversible and another had neurological problems.” The sixth volunteer has no symptoms, but is being closely monitored to make sure there are no brain injury signs that arise.
Some have speculated there may have been a drug impurity issue. This drug calls for an additional purification step to remove the “N-acetylated aniline impurity.” If this is not done properly, aniline can change hemoglobin to methemoglobin and impair oxygen delivery to tissues – resulting in acute aniline poisoning.
The French health ministry stated they sent agents to the trial clinic immediately following the announcement to determine if all of the rules were adhered to during the testing and also if the facility was sanitary.