Safety And Tolerability of Multiple-Dose Aripiprazole 2-Month Ready-to-Use 960 mg Versus Aripiprazole Once-Monthly 400 mg in Adults With Schizophrenia or Bipolar I Disorder

Abstract: Background: Aripiprazole 2-month ready-to-use 960 mg (2MRTU 960) is a new long-acting injectable (LAI) antipsychotic formulation for gluteal administration every 2 months, intended for the treatment of schizophrenia and maintenance monotherapy treatment of bipolar I disorder (BP-I). This 32-week trial evaluated the safety, tolerability, and pharmacokinetic profile of multiple-dose gluteal administration of 2MRTU 960 in adult patients with a diagnosis of schizophrenia or BP-I, versus that of aripiprazole once-monthly 400 mg (AOM 400; an LAI indicated for the treatment of schizophrenia and maintenance monotherapy treatment of BP-I). Methods: Eligible patients (Nf266) were randomized to receive 2MRTU 960 every 56±2 days (n=132; 4 injections in total) or AOM 400 every 28±2 days (n=134; 8 injections in total). Safety and tolerability were evaluated throughout the study. Results: The overall incidence of treatment-emergent adverse events (TEAEs) was similar between 2MRTU 960 and AOM 400 (71.2% versus 70.9%, respectively). The most frequently reported TEAEs were increased weight (22.7% for 2MRTU 960 versus 20.9% for AOM 400) and injection site pain (18.2% for 2MRTU 960 versus 9.0% for AOM 400), none of which were assessed as serious or severe by the investigators. All injection site pain events in the 2MRTU 960 group were assessed as mild or moderate in severity; most (15.9%) coincided with the first injection and resolved within 5 days. Extrapyramidal symptom scores remained unchanged in both treatment groups. Conclusions: Multiple-dose administration of 2MRTU 960 was generally well tolerated in patients with schizophrenia or BP-I and did not show any new safety concerns.Short Description: Aripiprazole 2-month ready-to-use 960 mg (2MRTU 960) is a new long-acting injectable antipsychotic formulation for gluteal administration every 2 months, intended for the treatment of schizophrenia and maintenance monotherapy treatment of bipolar I disorder (BP-I). This 32-week trial evaluated the safety, tolerability, and pharmacokinetics of 2MRTU 960 versus that of aripiprazole once-monthly 400 mg, in patients with schizophrenia or BP-I. 2MRTU 960 was generally well tolerated and did not show any new safety concerns.Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA H. Lundbeck A/S, Valby, Denmark