Johnson & Johnson Pharmaceutical Research & Development Submits New Drug Application For Paliperidone Palmitate

Titusville, NJ - Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for paliperidone palmitate, an investigational, once-monthly atypical antipsychotic intramuscular injection, for the treatment of schizophrenia and the prevention of recurrence of the symptoms of schizophrenia.

Paliperidone palmitate is a long-acting injectable ester of the active ingredient in INVEGA which utilizes Elan's NanoCrystal Technology. Upon approval, paliperidone palmitate will be marketed in the U.S. by Janssen, L.P.

Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness. In the United States, there are currently 2,000,000 people with schizophrenia, with men and women affected equally. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions, and social withdrawal), as well as by disorganized thinking.

SOURCE: J&JPRD