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PubMed · 42628238

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

Christoph U Correll·John M Kane·Mark Suett·Kelli R Franzenburg·Rolf Hansen·Nir Sharon·Anna Elgart·Antoanela Stanilescu·Eran Harary·Orna Tohami
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Abstract

TV-46000 is a long-acting injectable antipsychotic (LAI) approved for the treatment of adults with schizophrenia and bipolar I disorder. LAIs like TV-46000 can improve adherence and reduce relapse in patients with schizophrenia; however, injection site reactions (ISRs) can contribute to LAI discontinuation. ISRs with TV-46000 treatment were characterized using data from two phase 3 trials of patients with schizophrenia (RISE [NCT03503318], SHINE [NCT03893825]) and a phase 1 study of patients with schizophrenia or schizoaffective disorder. Patients in the pooled safety population (aged 16-67 years) from RISE and SHINE (n = 525 TV-46000, n = 179 placebo) received 4554 TV-46000 injections and 2721 placebo injections. ISRs were reported in 19 % (n = 102) of patients who received TV-46000, corresponding to an exposure-adjusted event rate (EAER)/100 patient-years of 48.67. ISRs led to 9 (1.7 %) treatment discontinuations of TV-46000. The most frequently reported ISR adverse events were injection site pain (EAER, 15.38, n = 36 [7 %]) and injection site nodule (EAER, 12.01, n = 35 [7 %]). ISR frequency and pain and nodule adverse event frequency decreased after the first injection. In the phase 1 study (n = 99), mean injection site pain scores were highest immediately after injection, showed a notable decrease within 10 min of injection, and further decreased within 1 h after injection. In conclusion, for >4500 injections evaluated, ISR rates with TV-46000 were modest. Most ISRs were mild or moderate and rarely led to treatment discontinuation. Results support the favorable tolerability of TV-46000 as a treatment for schizophrenia in adults.

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HumansSchizophreniaAdultMiddle AgedAntipsychotic AgentsMaleFemaleRisperidoneYoung AdultDelayed-Action PreparationsAdolescentAgedPsychotic DisordersInjection Site ReactionInjections, SubcutaneousInjection site reactionsLong-acting injectable antipsychotic (LAI)PainSafetyTV-46000Journal ArticleClinical Trial, Phase IRandomized Controlled TrialClinical Trial, Phase III

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Christoph U Correll, John M Kane, Mark Suett, Kelli R Franzenburg, Rolf Hansen, Nir Sharon, Anna Elgart, Antoanela Stanilescu, Eran Harary, Orna Tohami. 2026-08-06. Characterization of local tolerability of TV-46000, a long-acting subcutaneous formulation of risperidone for the treatment of schizophrenia.. https://doi.org/10.1016/j.jpsychires.2026.08.002

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Adolescent subjectAdult subjectAged subjectAntipsychotic Agents subjectClinical Trial, Phase I subjectClinical Trial, Phase III subjectFemale subjectHumans subjectInjections, Subcutaneous subjectJournal Article subjectMale subjectMiddle Aged subjectPain subjectRandomized controlled trials study

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