Single dose injectable antipsychotic approved for initiating schizophrenia treatment
The U.S. Food and Drug Administration (FDA) has approved Alkermes's Aristada Initio (aripiprazole lauroxil) for the initiation of Aristada, a long-acting injectable atypical antipsychotic medication, for the treatment of schizophrenia in adults.
It may replace the 21-day initiation regimen of aripiprazole lauroxil with daily oral doses of aripiprazole following the first injection of the long-acting agent.
Schizophrenia is a chronic, severe and disabling brain disorder. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions, and social withdrawal), as well as by disorganized thinking.
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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.
The new product "provides patients with relevant levels of aripiprazole within four days of initiation," Alkermes said.
Aristada Initio and Aristada both contain aripiprazole lauroxil; however, the two medications are not interchangeable because of differing pharmacokinetic profiles. Aristada Initio is designed to provide an extended-release formulation using a smaller particle size of aripiprazole lauroxil compared to Aristada, thereby enabling faster dissolution and leading to more rapid achievement of relevant levels of aripiprazole.
Aristada Initio and Aristada however, are not approved for the treatment of patients with dementia-related psychosis.
Administered in a hospital setting, Aristada Initio features novel nano-crystalline technology allowing faster absorption of the treatment leading to a quicker achievement of target aripiprazole levels, according to the firm.
Following administration of Aristada Initio, the first dose of standard aripiprazole lauroxil -- which has several approved dosings, including 441 mg, 662 mg, and 882 mg monthly; 882 mg once every 6 weeks; and 1,064 mg once every 2 months -- can also be given the same day or within 10 days thereafter.
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