The Medical Letter on Drugs and Therapeutics
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1256
Paliperidone (Invega) for Schizophrenia
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Paliperidone (Invega – Janssen) has been approved by the FDA in an extended-release formulation for treatment of schizophrenia. It is the primary active metabolite of the second-generation antipsychotic risperidone (Risperdal – Janssen), which is scheduled to lose its patent exclusivity in December 2007.

PHARMACOLOGY — Paliperidone is well absorbed from the gastrointestinal tract, but because the osmotic delivery system used in the Invega formulation continuously releases variable amounts of drug throughout the day, serum concentrations take 24 hours to reach a peak and 4-5 days to achieve steady state.

CLINICAL STUDIES — Few clinical studies of paliperidone have been published. FDA approval was based on three similar 6-week, fixed-dose trials, including a total of 1665 subjects with schizophrenia. Olanzapine 10 mg was included as an active control and was similar ... more      

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Title: Paliperidone (Invega) for Schizophrenia
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