Pharmacokinetic Evaluation of a 1-Day Treatment Initiation Option for Starting Long-Acting Aripiprazole Lauroxil for Schizophrenia

Journal of Clinical Psychopharmacology
Marjie L HardLisa von Moltke

Abstract

Aripiprazole lauroxil (AL), a long-acting injectable antipsychotic for the treatment of schizophrenia, requires 21 days of oral aripiprazole supplementation upon initiation. We report findings from a phase 1 study investigating a nanocrystalline milled dispersion of AL (ALNCD) as a potential 1-day initiation regimen. The 1-day initiation regimen is designed to enable rapid achievement of plasma aripiprazole concentrations that are comparable with the 21-day oral initiation regimen. Here, a 6-month pharmacokinetic study compared 2 different initiation regimens for starting AL. Patients were randomized 1:1:1:1 to receive 1 of 4 treatments consisting of the 1-day (single ALNCD injection + one 30-mg dose of oral aripiprazole on day 1 only) or the 21-day (15-mg daily dose of oral aripiprazole for 21 days) initiation regimen, each combined with a starting AL dose of either 441 mg or 882 mg. In total, 133/161 patients completed the study. The pharmacokinetic profile of the 1-day initiation regimen was comparable to the 21-day initiation regimen; both achieved aripiprazole concentrations in the therapeutic range within 4 days and remained in a comparable concentration range during treatment initiation. Common adverse events (≥5.0%) wer...Continue Reading

References

Feb 21, 2003·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Elaine Merisko-LiversidgeEugene R Cooper
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Feb 17, 2017·The International Journal of Neuropsychopharmacology·Arash RaoufiniaFrank Larsen
Mar 30, 2017·Journal of Clinical Psychopharmacology·Marjie L HardLeslie Citrome

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Citations

Nov 17, 2020·Therapeutic Drug Monitoring·Georgios SchoretsanitisChristoph Hiemke
Mar 16, 2021·CNS Spectrums·Leslie Citrome
Nov 30, 2021·Current Psychiatry Reports·Mehak PahwaRif S El-Mallakh

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Clinical Trials Mentioned

NCT01469039

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