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Long-acting injectable antipsychotics

Psychiatryยท 2 reviewed drugsยท 572 cited findings behind them

What the regulatory reviews cover

The library includes several long-acting injectable antipsychotics that have undergone regulatory review for the treatment of schizophrenia. Aristada Initio was reviewed for the initiation of treatment of schizophrenia, with a Mean Cmax (aripiprazole) in the ALKS 9072N Initiation / AL 441 mg group reported as 268.15. Byannli was reviewed for the maintenance treatment of schizophrenia in adult patients stabilized with paliperidone or risperidone, with an Estimated Relapse Rate (Kaplan Meier model) for PP6M reported as 8.1. It is important to note that different drugs were studied in different trials, and therefore, the reported figures are not head-to-head comparisons.

The drugs โ€” one cited result each

Aristada Initio

Alkermes plc

Mean Cmax (aripiprazole) in ALKS 9072N Initiation / AL 441 mg group: 268.15

Alkermes plc โ€” Aristada FDA Review (NDA209830, ORIG 1, 2018), p.39

Byannli

Unknown MAH

Estimated Relapse Rate (Kaplan Meier model) for PP6M: 8.1

Unknown MAH โ€” Byannli (previously Paliperidone Janssen-Cilag, p.56

Different drugs were studied in different trials โ€” these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs โ€” searchable, comparable and answerable in plain language โ€” is in the Psychiatry research library โ†’

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only โ€” not medical or investment advice.

Long-acting injectable antipsychotics โ€” 2 Drugs Compared from FDA & EMA Reviews | BioPharmaPT Psychiatry