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J&J Halts Trials of Drug Similar to One Linked to Brain Death in France
Johnson & Johnson (J&J) has suspended international trials of a drug in the same class as an investigational compound made by Portuguese pharma company Bial, whose tests in France left one person brain-dead and five others hospitalized, according to a report from Reuters.
A J&J spokesman told the news agency in an emailed statement that the company has voluntarily halted two mid-stage studies in patients with social anxiety disorder and with major depressive disorder with anxious distress.
Approximately 120 patients have been treated with J&J’s experimental drug. Target enrollment for the social anxiety disorder study was 122 patients, while the major depressive disorder with anxious distress trial aimed to enroll 140 patients.
J&J said that few adverse events were reported during earlier phase 1 studies. In three patients given 100 mg of the drug daily for 10 days, increased liver enzyme levels were seen, but those levels returned to baseline when the drug was stopped. The company said its phase 2 trials were testing a 25-mg once-daily dosage, and there had been no observed effects on liver enzymes.
In France, all trials of the Bial drug have been suspended, and all volunteers who took part in the study are being called back. French prosecutors have opened an investigation into the case.
Both the Bial and J&J drugs are fatty acid amide hydrolase (FAAH) inhibitors that work by targeting the body’s endocannabinoid system, which is also responsible for the human response to cannabis.
Source: Reuters; January 22, 2016.