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news.Johnson & Johnson Pharmaceutical R&D, a subsidiary of Johnson & Johnson, has submitted multiple applications to the FDA which, if approved, would broaden treatment options for patients diagnosed with schizophrenia or schizoaffective disorder.
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Earlier, the company submitted its response to the FDA complete response letter for paliperidone palmitate, received in August 2008. Paliperidone palmitate is an investigational once-monthly atypical antipsychotic injection which, if approved, will be indicated for the acute and maintenance treatment of schizophrenia.
The company has also submitted two supplemental new drug applications (sNDAs) to the FDA requesting approval for the use of Invega tablets for the treatment of schizoaffective disorder as monotherapy and for use in combination with antidepressants 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. If approved by the FDA, Invega would be the only medication indicated to treat the condition, the company said.
Invega, an atypical antipsychotic medication, was first approved in the US in December 2006 and is marketed by Janssen. It is approved for the acute and maintenance treatment of schizophrenia in the US and for the treatment of schizophrenia in the EU. If approved, Janssen will also market paliperidone palmitate.