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J&J announce filings to FDA for schizophrenia drug


Johnson & JohnsonPharmaceutical Research & Development, have announced that the company has submitted multiple applications to theUS Food and Drug Administration (FDA) which, if approved, wouldbroaden treatment options for patients diagnosed with schizophrenia orschizoaffective disorder.

Early last week, the company submitted its response to the FDAcomplete response letter for paliperidone palmitate, received in August2008. Paliperidone palmitate is an investigational once-monthlyatypical antipsychotic injection which, if approved, will be indicatedfor the acute and maintenance treatment of schizophrenia.

The company also submitted two supplemental new drug applications(sNDAs) to the FDA requesting approval for the use of Invega tabletsfor the treatment of schizoaffective disorder as monotherapy and foruse in combination with antidepressants and/or mood stabilisers.

ThesNDA submissions include data from two international, 6-weekdouble-blind placebo-controlled studies that evaluated the efficacy andsafety of Invega in patients with schizoaffective disorder. If approvedby the FDA, Invega would be the only medication indicated to treat thecondition.

Patients with schizoaffective disorder experience the psychoticsymptoms of schizophrenia, such as hallucinations or delusions, as wellas mania and/or depression. Because of the similarity in symptoms,schizoaffective disorder is sometimes misdiagnosed as schizophrenia orbipolar disorder. For patients who frequently use mental healthservices, schizophrenia and schizoaffective disorder may account forapproximately 32% and 24% of cases respectively.

Invega, an atypical antipsychotic medication, was first approved inthe US in December 2006 and is marketed by Janssen. It is approvedfor the acute and maintenance treatment of schizophrenia in the USand for the treatment of schizophrenia in the EU. If approved, Janssenwill also market paliperidone palmitate.

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Johnson & Johnson


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