FDA stops pain drug trial over safety concerns

By Dr. Ananya Mandal, MDDec 29 2010

Johnson & Johnson revealed Tuesday this week that a clinical trial of its experimental pain drug, fulranumab, has been stopped after the Food and Drug Administration expressed concerns that patients taking the drug could suffer increased joint damage.

Fulranumab belongs to a class of drugs called nerve growth factor inhibitors that block osteoarthritis pain by reducing a protein linked to the condition. Osteoarthritis is a chronic disease and leads to the eventual loss of cartilage in the joints.

However the FDA has investigated reports that some patients treated with the drugs could suffer from rapidly progressive osteoarthritis, a wearing away of the cartilage protecting bone joints, or osteonecrosis, the death of bone tissue due to a lack of blood supply.

The FDA’s intervention also stopped AstraZeneca PLC's Medimmune unit’s drug MEDI-578 in July after Pfizer Inc. stopped a similar trial. Pfizer had halted studies of its drug, tanezumab, at the request of the FDA. Regeneron Pharmaceuticals Inc. and Sanofi-Aventis SA disclosed this Monday that they had also halted a study of their inhibitor drug after being contacted by the FDA. The extent of injuries to the patients is not known yet.