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Plasma concentrations and dosing of 2 long-acting injectable formulations of aripiprazole

Authors Salzman PM, Raoufinia A, Legacy S, Such P, Eramo A

Received 28 January 2017

Accepted for publication 14 March 2017

Published 20 April 2017 Volume 2017:13 Pages 1125—1129


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Roger Pinder

Phyllis M Salzman,1 Arash Raoufinia,2 Susan Legacy,3 Pedro Such,4 Anna Eramo5

1Global Medical Affairs, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, 2Clinical Pharmacology, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD, 3US Medical Affairs, Neuroscience, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 4Medical Affairs Psychiatry, H. Lundbeck A/S, Valby, Denmark; 5Global Clinical Development, CNS, Lundbeck LLC, Deerfield, IL, USA

Abstract: Maintaining therapeutic plasma concentrations of an antipsychotic agent is essential in preventing relapse of symptoms in schizophrenia. Long-acting injectable (LAI) formulations provide extended exposure to antipsychotic therapy and have been useful in addressing treatment nonadherence. Aripiprazole is an atypical antipsychotic used in the treatment of schizophrenia and is available in 2 chemically different (aripiprazole monohydrate and aripiprazole lauroxil [AL]) and pharmaceutically different LAI formulations (aripiprazole once-monthly 400 mg [AOM 400] and AL). The pharmaceutical difference is that AL, unlike AOM 400, is a prodrug that requires additional metabolic steps to form the active drug aripiprazole. We present data demonstrating that aripiprazole plasma concentrations are similar for AOM 400 and the 882 mg dose of AL when administered once every 4 weeks and that both provide similar therapeutic plasma concentrations of aripiprazole when compared with therapeutic oral doses.

Keywords: long-acting injectable, aripiprazole, plasma concentrations, dosing, schizophrenia

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