Aripiprazole once-every-two-months long-acting injectable recommended for approval by the CHMP for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole

Aripiprazole once-every-two-months LAI is a new formulation containing 960mg aripiprazole provided in a single-chamber prefilled syringe that does not require reconstitution1. It is intended for dosing once every two months via intramuscular injection into the gluteal muscle. If approved, the drug would be the first once-every-two-months 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 and several studies have demonstrated that a predictor for further relapse is nonadherence to antipsychotic medications. An LAI formulation enables 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. In patients with schizophrenia, LAI formulations have been shown to increase adherence and reduce relapse rates versus oral antipsychotics.

The CHMP based its positive opinion on the safety and efficacy of the drug, which has been demonstrated in a 32-week pharmacokinetic bridging trial. Aripiprazole once-every-two-months LAI was shown to provide similar plasma concentrations, and therefore similar effectiveness, as well as a similar safety and tolerability profile to aripiprazole once-monthly LAI in 266 adults, of which 185 were diagnosed with schizophrenia