Aristada Initio(Aripiprazole lauroxil)

Aristada Initio (aripiprazole lauroxil) is an extended-release injectable suspension. The original formulation of Aristada was approved on October 5, 2015, with an additional dosing schedule of 1064 mg IM every eight weeks approved on June 5, 2017. The application number for Aristada Initio is 209830, and its approval was recommended.

Efficacy findings for aripiprazole Cmax include a mean of 268.15 ng/mL in the ALKS 9072N Initiation / AL 441 mg group and 217.53 ng/mL in the ALKS 9072N Initiation / AL 882 mg group. For oral initiation, mean Cmax values were 191.69 ng/mL for the AL 441 mg group and 220.64 ng/mL for the AL 882 mg group. Median Tmax values ranged from 16.5 days to 27.0 days across different initiation and dosage groups. Mean AUC0-28 values ranged from 3371.6 day*ng/mL to 4256.4 day*ng/mL, and mean AUClast values ranged from 6104.9 day*ng/mL to 11627.2 day*ng/mL.

Safety considerations include QTcF exclusion criteria of 450 msec for men and 470 msec for women. No new safety signals were identified. A 2-fold increase in aripiprazole concentrations was observed for CYP2D6 poor metabolizers, and a 1.5-fold increase with strong CYP3A4 inhibitors. The upper end of the therapeutic range for oral aripiprazole (Cmax at steady-state for a 30 mg oral dose) is 435 ng/mL. The Aristada Initio single dose strength is 675 mg.