J&JPRD Files Schizophrenia Drugs

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted multiple applications to the FDA for the treatment of schizophrenia.

The company submitted its response to the FDA complete response letter for paliperidone palmitate, an investigational once-monthly atypical antipsychotic injection. If approved, the drug will be indicated for the acute and maintenance treatment of schizophrenia.

The company also submitted two sNDAs requesting approval for the use of Invega (paliperidone) tablets for the treatment of schizoaffective disorder as monotherapy and for use in combination with antidepressants and/or mood stabilizers. The sNDA submissions include data from two international, six-week double-blind placebo-controlled studies that evaluated the efficacy and safety of Invega in patients with schizoaffective disorder.  

Invega was first approved in the U.S. in December 2006 and is marketed by Janssen. It is approved for the acute and maintenance treatment of schizophrenia in the U.S. and for the treatment of schizophrenia in the E.U. If approved, Janssen will also market paliperidone palmitate.