Yes, Aristada (aripiprazole lauroxil) is FDA-approved for treating schizophrenia in adults.[1][2]
How does Aristada work for schizophrenia?
Aristada is a long-acting injectable atypical antipsychotic. It converts to aripiprazole in the body, blocking dopamine and serotonin receptors to reduce hallucinations, delusions, and disorganized thinking.[1][3] Doses range from 441 mg to 1064 mg intramuscularly, given every 4 to 8 weeks after initial dosing.[2]
Who can take Aristada and when is it prescribed?
It's approved for adults with schizophrenia, often as maintenance therapy to improve adherence over daily oral antipsychotics. It's not for acute agitation or children under 18.[1][2] Doctors start with a single 661 mg dose, sometimes paired with an oral antipsychotic for 21 days.[3]
What are common side effects?
Patients report akathisia (restlessness, 12-17%), weight gain (up to 10%), injection-site pain, and sedation. Serious risks include tardive dyskinesia, neuroleptic malignant syndrome, and high blood sugar. Monitoring is required.[1][2]
How does Aristada compare to other schizophrenia treatments?
Unlike short-acting oral meds like Abilify (daily aripiprazole), Aristada lasts weeks, cutting relapse risk from non-adherence. Competitors include Invega Sustenna (paliperidone, monthly) and Abilify Maintena (aripiprazole, monthly). Studies show similar efficacy but better convenience for some.[3][4]
Who makes Aristada and what's the patent status?
Alkermes manufactures it. Key U.S. patents expire in 2030, with others challenged in litigation; generics unlikely before then.[5]
[1]: FDA Label - Aristada (aripiprazole lauroxil). https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207533lbl.pdf
[2]: Aristada Prescribing Information. https://aristada.com/
[3]: Clinical Pharmacology Review. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5433622/
[4]: Schizophrenia Treatment Guidelines (APA). https://www.psychiatry.org/psychiatrists/practice/clinical-practice-guidelines
[5]: DrugPatentWatch.com - Aristada Patents. https://www.drugpatentwatch.com/p/tradename/ARISTADA