The USFDA has recently approved aripiprazole, a long-acting atypical antipsychotic for treating schizophrenia and as a maintenance monotherapy for bipolar I disorder in adults. It is an injectable formulation in 960 and 720 mg prefilled syringes. Clinical trial data The FDA approval is based on well-controlled studies involving adults with schizophrenia or bipolar I disorder. A 32-week, open-label, randomized, parallel-arm, multicenter study explored the aripiprazole concentration in patients with schizophrenia and bipolar I disorder (n=266).
The once-every-two-months, long-acting injectable formulation of 960 and 720 mg prefilled syringes achieved sustained plasma concentrations comparable to previously approved once-monthly, long-acting injectable aripiprazole monohydrate (400 mg). Both showed similar safety profiles including injection site pain (Table1). Table1: Injection site pain…
