The FDA is looking into the safety of one treatment from the FAAH inhibitor class after a patient died and 5 were severely injured--they took high doses of a drug from this class at the start of the year.
The U.S. regulator said it was working alongside its European counterpart, the EMA, as well the French regulator to assess BIA 10-2474.
The drug was being trialed by French CRO Biotrial and its Portuguese pharma partner Bial in Rennes, France, in January when the patient died and others become acutely ill.
The French CRO was running a Phase I trial on behalf of Portuguese drugmaker Bial, administering BIA 10-2474, a medicine that blocks the enzyme FAAH to treat anxiety.
The drug's mechanism is well known to the industry but had not shown safety concerns in previous testing--although French news reports surfaced in March that there had been some unusual deaths and issues in preclinical trials of the drug, which had seemingly not been acted upon.
In all, about 100 patients had taken the drug, but in January, 6 trial participants took a higher dose form of the treatment, with one becoming brain-dead and later dying.
The FDA said in a statement that there are currently no trials of the drug underway in the U.S., but it is still looking into its safety given the death in France. The EMA is also conducting a review into how all Phase I trials are managed.
The FDA said it has found, based on the available information, that “BIA 10-2474 exhibits a unique toxicity that does not extend to other drugs in the class, called fatty acid amide hydrolase (FAAH) inhibitors.”
A number of reports have since been published about the causes of the death and injuries, with all pointing to the toxicity of BIA 10-2474 at its highest doses as being the main culprit.
Both Bial and Biotrial have also received some criticism for the way the patients were helped after being given a high dose of the drug, with one report concluding that both “lacked common sense.” Neither have been directly blamed, but reports have said they must share some responsibility for what happened.
In a statement, the FDA said: “Based on these findings [of the official reports into the death], the FDA is working with sponsors to establish the appropriate path forward for FAAH inhibitors under investigation in the U.S.
“We are also working to ensure healthy subjects, patients, and investigators participating in FAAH inhibitor clinical trials are fully informed of the risks and potential benefits of these experimental therapies.”
- see the FDA update
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