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Aripiprazole lauroxil shows favorable long-term safety and efficacy in schizophrenia

Key clinical point: Treatment with intramuscular aripiprazole lauroxil shows significant tolerability and continued therapeutic efficacy in adults with schizophrenia in the long term (up to 180 weeks).

Major finding: 57.5% of the patients had adverse events across 2 studies (441 mg: 52.7%; 882 mg: 59.0%), of which 12.8% reported extrapyramidal-related adverse events (441 mg: 9.1%; 882 mg: 13.9%). Both doses significantly reduced (P less than .001) positive and negative syndrome scale score between weeks 12 and 124, indicating continued symptom improvement beyond the initial year of treatment.

Study details: The data come from 2 consecutive long-term extension studies involving 478 patients with schizophrenia who received an aripiprazole lauroxil dose of either 441 mg or 882 mg intramuscularly every 4 weeks for up to 3.5 years.

Disclosures: This study was funded by Alkermes, Inc. Dr. John Lauriello is a speaker/advisory board member/event monitoring board member for various pharmaceutical companies including Alkermes and Roche. Dr. Amy Claxton and Dr. Yangchun Du are employees of Alkermes, Inc, and may own stock/options in the company. Dr. Peter J Weiden is a former employee of Alkermes, Inc, and may own stock/options in the company.


Lauriello J et al. J Clin Psychiatry. 2020 Aug 18. doi: 10.4088/JCP.19m12835.