January 21, 2016 / 10:10 PM / 4 years ago

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

Jan 21 (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’s Janssen research and development unit said in an emailed statement that it voluntarily suspended two mid-stage trials and has 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.

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 drugs 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.

Bial said in a statement last week it was committed to ensuring the wellbeing of test participants and was working with authorities to discover the cause of the injuries.

Cases of early-stage clinical trials going badly wrong are rare but not unheard of. In 2006, six healthy volunteers given an experimental drug in London ended up in intensive care. One was described as looking like “the elephant man” after his head ballooned. Another lost his fingertips and toes.

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 and what is 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 are finally approved for sale.

The 2006 London trial led to the collapse of Germany’s TeGenero, the company developing a medicine known as TGN1412. The drug has since gone back into tests for rheumatoid arthritis and is showing promise when given at a fraction of the original dose. (Reporting By Deena Beasley; Editing by David Gregorio)

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