Scientific Publications by FDA Staff

J Clin Psychopharmacol 2013 Apr;33(2):152-6

An Integrated Approach for Establishing Dosing Recommendations: Paliperidone for the Treatment of Adolescent Schizophrenia.

Younis IR, Laughren TP, Wang Y, Mathis M, Gobburu JV

The Food and Drug Administration recently approved Invega for the treatment of schizophrenia in adolescents 12 to 17 years. If dosing recommendations for this population would have been based only on the results of the single efficacy trial included in this program, paliperidone dosing in adolescents might have been limited to 3 mg/d in adolescents less than 51 kg and to 6 mg/d in adolescents greater than or equal to 51 kg. This article provides an illustration of a more integrated approach to arrive at dosing recommendation that included practical considerations, modeling and simulation of data from the clinical trial, and the totality of evidence for both paliperidone and the parent drug, risperidone. On the basis of this integrated approach, the agency approved a starting dose of 3 mg/d in both adolescent weight groups and subsequent dosing in a range of 3 to 6 mg/d for adolescents less than 51 kg and 3 to 12 mg/d for adolescents greater than 51 kg, although the 3-mg dose was not evaluated in the greater than or equal to 51-kg group.