Abstract
A long-acting intramuscular formulation of the atypical antipsychotic agent risperidone is now indicated for the maintenance treatment of patients with bipolar I disorder.
The formulation utilizes a novel drug delivery system of biodegradable microspheres and is bioequivalent to the oral formulation of the drug. Moreover, fluctuations in plasma drug concentrations at steady state were 1.7-fold lower with long-acting than with oral risperidone.
Maintenance treatment with risperidone long-acting injection, as monotherapy in adults with stabilized bipolar I disorder or as an adjunct to standard therapy in adults with stabilized, frequently relapsing bipolar I disorder, was effective in delaying relapse to symptoms in two well designed trials with maintenance phases of 1 or 2 years’ duration. The time to relapse to any mood episode (primary endpoint) was significantly longer with risperidone long-acting injection than with placebo in both studies.
Risperidone long-acting injection also significantly reduced the risk of relapse relative to placebo in these trials.
Maintenance treatment with risperidone long-acting injection was generally well tolerated in patients with bipolar disorder, both as monotherapy and adjunctive therapy, with most adverse reactions being of mild to moderate severity.
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Acknowledgements and Disclosures
This manuscript was reviewed by: P.B. Mitchell, School of Psychiatry, University of New South Wales, Sydney, New South Wales, Australia; R.M. Post, George Washington University, Washington, DC, USA; J.F. Rosenbaum, Department of Psychiatry, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA.
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
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Deeks, E.D. Risperidone Long-Acting Injection. Drugs 70, 1001–1012 (2010). https://doi.org/10.2165/11204480-000000000-00000
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DOI: https://doi.org/10.2165/11204480-000000000-00000