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Invega Phase IV examines lower doses

Executive Summary

Johnson & Johnson will seek to identify a minimal effective dose for Invega (paliperidone extended-release) during post-marketing studies; a study protocol is due to FDA by April. Data supporting approval for the schizophrenia agent suggest the lower end of the dose-response curve has not been fully evaluated, according to the agency's Dec. 19 approval letter (1"The Pink Sheet" Jan. 1, 2007, p. 5). J&J plans to market Invega with the sales force that currently markets the atypical antipsychotic Risperdal (risperidone), without adding reps. The product, a metabolite of Risperdal, has begun shipping...

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