Characterization of local tolerability of TV-46000, a long-acting subcutaneous formulation of risperidone for the treatment of schizophrenia.

J Psychiatr ResAug 6, 2026 (epub)
Clinical ResearchPsychiatry

Christoph U Correll, John M Kane, Mark Suett et al.

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In 30 seconds

This study evaluated the local tolerability of TV-46000, a long-acting injectable formulation of risperidone, in adults with schizophrenia. Data from two phase 3 trials and one phase 1 study indicated that injection site reactions (ISRs) occurred in 19% of patients receiving TV-46000, with a notable decrease in ISR frequency after the first injection. The study design was a randomized controlled trial.

Key findings

  • Injection site reactions occurred in 19% of patients receiving TV-46000.
  • The exposure-adjusted event rate for ISRs was 48.67 per 100 patient-years.
  • Most ISRs were mild or moderate, leading to only 1.7% treatment discontinuations.
  • Mean injection site pain scores decreased significantly within 1 hour post-injection.

Why it matters

Understanding the tolerability of long-acting injectable antipsychotics is crucial for improving patient adherence and reducing relapse rates in schizophrenia. This study highlights the manageable nature of ISRs associated with TV-46000.

Source

PubMed · PMID 42628238

Published in J Psychiatr Res. This summary was written by xxcode from the publication's abstract and metadata. It is not peer reviewed and is not a substitute for the original article. For clinical decisions, review the original publication.

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