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European Medicines Agency Commences Review of Aripiprazole 2-Month Long-Acting Injectable for the Maintenance Treatment of Schizophrenia in Adult Patients Stabilised with Aripiprazole

Otsuka Pharmaceutical Europe Ltd

LONDON, UK, 17 June 2022 – Otsuka Pharmaceutical Europe Ltd. (“Otsuka”) and H. Lundbeck A/S (“Lundbeck”) today announce that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for aripiprazole as a 2-month ready-to-use (RTU) long-acting injectable (LAI) for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole.

Aripiprazole 2-month RTU LAI is a new formulation provided in a single chamber prefilled syringe that does not require reconstitution1. It is intended for dosing every two months via intramuscular injection into the gluteal muscle, in the same patient population as indicated for Abilify Maintena® (aripiprazole once-monthly LAI) (1). If approved, aripiprazole 2-month RTU LAI would be the first 2-month LAI antipsychotic licensed in the EU indicated for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole.

Medication adherence in patients with schizophrenia is generally poor (2) and several studies have demonstrated that a predictor for further relapse is nonadherence to antipsychotic medications (3). A long-acting injectable formulation ensures continuous exposure to medication and through a simplified treatment regimen, many of the challenges with poor treatment adherence may be mitigated, resulting in a potential positive impact on patient outcomes (4). In patients with schizophrenia, long-acting injectable formulations have been shown to increase adherence and reduce relapse rates versus oral antipsychotics (4, 5, 6).

The MAA is supported by findings from a pharmacokinetic bridging study that examined the safety, tolerability and pharmacokinetics of aripiprazole 2-month RTU LAI 960 mg in 266 adults with schizophrenia or bipolar I disorder over the course of 32 weeks as compared to those from monthly administrations of aripiprazole 400 mg once-monthly over the same time course1. Results from the pivotal trial NCT04030143 (, demonstrated that aripiprazole RTU LAI 960 mg met the primary endpoint of establishing similar concentrations of aripiprazole over a 2-month dosing interval to those achieved with aripiprazole 400 mg once-monthly (1). Multiple-dose administrations of aripiprazole 2-month RTU LAI 960 mg were generally well-tolerated in subjects with schizophrenia or bipolar I disorder and did not show any new safety concerns compared to aripiprazole 400 mg once-monthly (1).

  1. Data on file. Otsuka UK/Pharma Europe Ltd. Aripiprazole 2M RTU LAI 960mg 031-201-00181 Ph1b Study- Primary endopoint results. OPE-AM-2200049.8-Jun-2022.
  2. Brissos S, et al. Ther Adv Psychopharmacol 2014; 4(5): 198–219
  3. Emsley R et al. BMC Psychiatry 2013;13:50
  4. Zhornitsky S & Stip E. Schizophr Res Treatment 2012; 2012:407171
  5. Agid O, et al. Expert Opin Pharmacother 2010; 11 (14): 2301–2317
  6. Leucht C, et al. Schizophr Res 2011;127(1–3): 83-92
  7. NICE. Aripiprazole. Available at: [Accessed: June 2022]
  8.[Accessed: June 2022]
  9. Kahn RS, et al. Nat Rev Dis Primers 2015; 1 (15067)
  10. World Health Organisation. Factsheet, Schizophrenia. Available at: [Accessed: June 2022]
  11. Global Burden of Disease Study 2016. Lancet 2017;390 (10100): 1211–1259
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