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FDA halts study on experimental medication


FDA halts study on experimental medication

nickj December 30, 2010

Studies involving the Johnson & Johnson pain medication fulranumab have been put on hold after the Food and Drug Administration raised concerns over an association between the drug and the potential for severe bone disorders. The announcement was made Tuesday and follows the stoppage of other similar products known as nerve growth factor inhibitors, Bloomberg reports.

The drug was designed to help treat pain in osteoporosis patients by reducing a protein that is present in those diagnosed with the condition. However, the biggest issue surrounding the drug is that FDA officials believe it can stop blood from flowing to joints, which can eventually cause the bone to collapse and necessitate a joint replacement.

Due to a similar side-effect, the study of other drugs being developed by pharmaceutical giants Pfizer and AstraZeneca were halted earlier this year after several test subjects needed joint replacement surgeries. Though AstraZeneca was not ordered by the FDA to stop its study, the organization did so as a precautionary measure.

The stoppage is a significant hit to Johnson & Johnson's business, as the pain medication was expected to generate $11 billion in annual sales. Now, investors are hesitant to put their money behind drugs that operate a similar way for fear of any backlash.

"You'd have to have a lot of safety data to ever get a drug like this approved, so for investors this is not a class that's generating very high hopes," Bakri told the news source. "You're not going to see many companies chasing these drugs at this point."

While the company has not announced when or how it plans to resolve the issue, a spokesperson for Johnson & Johnson said that they were going to work with the FDA to find a solution.