Johnson & Johnson stops trials of drug similar to one linked to brain death in France

(Reuters) - Johnson & Johnson has suspended international trials of a drug in the same class as an experimental drug made by Portuguese pharmaceutical company Bial, whose tests in France left one person brain dead and five others hospitalized. A spokesman for Johnson & Johnson said in an emailed statement that it voluntarily suspended two mid-stage trials and had not received reports of serious adverse events in its studies of patients with social anxiety disorder and major depressive disorder with anxious distress. He said J&J will re-evaluate its decision once it has more information. Officials in France have said 90 people have taken part in the Bial trial, taking some dosage of the drug aimed at tackling mood and anxiety issues, as well as movement coordination disorders linked to neurological issues. New Jersey-based J&J said that around 120 patients have so far been treated with its drug. Target enrolment for the social anxiety disorder study was 122 patients, while the major depressive disorder with anxious distress trial aimed to enrol 140 patients. J&J said very few side effects were reported during earlier Phase I studies. In three patients given 100 mg of the drug daily for 10 days, increased liver enzymes were seen, but levels returned to baseline when the drug was stopped. The company said its Phase II trials were testing 25 mg once daily and there have been no observed effects on liver enzymes. All trials of the Bial drug have been suspended and all volunteers who have taken part in the trial are being called back, French officials said. French prosecutors have opened an investigation into the case. The medicine involved in both the Bial and J&J drug is a so-called FAAH inhibitor that works by targeting the body's endocannabinoid system, which is also responsible for the human response to cannabis. Cases of early-stage clinical trials going badly wrong are rare but not unheard of. In 2006, six healthy volunteers given an experimental immune stimulant drug in London ended up in intensive care. In the initial Phase I stage of clinical testing, a drug is given to healthy volunteers to see how it is handled by the body in order to establish the right dose to give to patients. Medicines then go into larger Phase II and Phase III trials to assess their effectiveness and safety before they can be approved for sale. (Reporting By Deena Beasley; Editing by David Gregorio and Bill Rigby)