FDA deals J&J another Risperdal blow

This is the second time in recent weeks that the FDA has denied approval of Risperdal (risperidone) for the treatment of a new disease. Earlier this month Johnson & Johnson were told it would be unable to market Risperdal for the treatment of autism. The company has said it will evaluate the FDA’s decision before taking any further steps to market the drug.

The FDA has produced new warnings on drugs like Risperdal following findings linking such compounds to an increased death rate when used to treat dementia.

Risperdal works by blocking the serotonin and dopamine receptors in the brain. These two neurotransmitters have been implicated in diseases such as schizophrenia, the primary disorder Risperdal is aimed at treating. Although studies have shown this novel antipsychotic to be effective in reducing both positive and negative symptoms of schizophrenia, there is conflicting evidence regarding its effect on cognitive functioning, now recognized as a major symptom of the disease.

In other news, following the first whole-scale review of its pharmaceutical portfolio in four years, J&J stated that it expects to expand despite the loss of patent protection on some of its most profitable drugs. The company also plans to file for marketing approval for up to 13 new drug formulations by 2007 to further boost growth.