The Food and Drug Administration (FDA) has approved Aristada Initio (aripiprazole lauroxil extended-release injectable suspension; Alkermes), in combination with oral aripiprazole, for the initiation of Aristada (aripiprazole lauroxil extended-release injectable suspension; Alkermes) in the treatment of adults with schizophrenia. 

Specifically, patients with schizophrenia may now be started on any dose of Aristada on day 1 when Aristada Initio is given in combination with a single oral aripiprazole 30mg dose; the first Aristada dose can be given on the same day as Aristada Initio or up to 10 days thereafter. Aristada Initio can be used as a single dose to initiate patients on Aristada treatment or as a single dose to re-initiate Aristada following a missed dose; Aristada Initio is not for repeated dosing.  

Prior to this approval, the Aristada initiation regimen consisted of taking oral aripiprazole for 21 consecutive days starting with the first Aristada dose. With the addition of Aristada Initio and oral aripiprazole 30mg at the time of the first Aristada dose, aripiprazole concentrations reach relevant levels within 4 days. For patients who have never taken aripiprazole, tolerability with oral aripiprazole needs to be established before initiating treatment with Aristada Initio.

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Aristada and Aristada Initio, both atypical antipsychotics, are not interchangeable as they have different pharmacokinetic profiles. The initiation utilizes the Company’s proprietary NanoCrystal technology and is intended to provide an extended-release formulation through a smaller particle size compared with Aristada. This allows for quicker dissolution and achievement of relevant aripiprazole levels.

“The approval of Aristada Initio makes Aristada the first and only long-acting atypical antipsychotic that can be initiated on day one, representing an important addition to the treatment paradigm for the complex illness of schizophrenia,” said David Walling, Ph.D., Chief Executive Officer and Principal Investigator of the Collaborative Neuroscience Network. “For physicians and caregivers alike, the Aristada Initio regimen provides a level of confidence that patients can walk out the door with up to 2 months of coverage with a proven medication in their system.”

Aristada Initio is anticipated to launch in mid-July as a 675mg single-dose prefilled syringe. 

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