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Johnson & Johnson submits NDA for paliperidone

Johnson & Johnson has submitted a new drug application to the FDA for paliperidone palmitate, an investigational, once-monthly injection for the treatment of schizophrenia and prevention of recurring symptoms.

Paliperidone palmitate is a long-acting injectable ester of the active ingredient in Invega which utilizes Elan’s NanoCrystal Technology. If the new drug application (NDA) is approved, paliperidone palmitate will be marketed in the US by Janssen, a subsidiary of Johnson & Johnson dedicated solely to mental health, J&J said.

Schizophrenia is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions, and social withdrawal), as well as by disorganized thinking.