Lurasidone for the treatment of irritability and anger in autism spectrum disorders

ABSTRACT

Introduction: Autism Spectrum Disorder (ASD) is a heterogeneous neurodevelopmental disorder characterized by deficits in social interaction and communication as well as restricted patterns of behaviors and interests. Irritability marked by tantrums, self-injury and aggression occurs frequently in youth with ASD, causing significant parent and caregiver distress. Atypical antipsychotics have been the most studied drug class targeting irritability in ASD. Risperidone and aripiprazole are Food and Drug Administration (FDA)-approved atypical antipsychotics for treatment of irritability in youth with ASD. However, other atypical antipsychotics, such as lurasidone, are often considered for off-label use in the treatment of irritability, whether because of tolerability issues with risperidone and aripiprazole or because of the drug-refractory nature of this symptom cluster.

Areas covered: Following a comprehensive review of the literature this article summarizes information on the efficacy and tolerability of lurasidone as a potential off label treatment of irritability in children and adolescents with ASD. Available data included a 6 week randomized, blind, fixed dose, placebo-controlled study and a case study.

Expert opinion: To date the safety and tolerability of lurasidone in treating irritability in youth with ASD has yet to be established with, lurasidone being the only antipsychotic with published negative placebo-controlled results.

KEYWORDS:

• Autism
• children
• adolescent
• lurasidone
• atypical antipsychotics
• irritability
• anger

Declaration of interest

C. A. Erickson has received current or past support from Alcobra Pharmaceuticals, the American Academy of Child & Adolescent Psychiatry, Autism Speaks, Cincinnati Children’s Hospital Medical Center, FRAXA Research Foundation, Hoffman-La Roche Inc., Neuren Pharmaceuticals Limited, Simons Foundation Autism Research Initiative, Stemina Biomarker Discovery Inc., SynapDx, The John Merck Fund, the National Fragile X Foundation, the National Institutes of Health, and the US Department of Defense. C. A. Erickson has also previously served as a consultant to Alcobra, Neurotrope, The Roche Group, Novartis and is a current consultant to Confluence Pharmaceuticals and Fulcrum Therapeutics. He is also an equity holder in Confluence Pharmaceuticals. L. K. Wink has previously served as a consultant to Otsuka Pharmaceuticals, she receives research support from the Nancy Lurie Marks Foundation, the Simons Foundation, Ovid Pharmaceuticals, the Roche Group, Stemina Biomarker Discovery Inc. and SynapDx. E. V. Pedapati receives research support from the Cincinnati Children’s Hospital Research Foundation and the National Institutes of Health. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This paper was not funded.