Safety of TV-46000, long-acting injection for schizophrenia, consistent in phase 3 study
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Key takeaways:
- Rates of adverse events were similar in both dosing groups.
- Findings from this study add to the consistent and favorable safety profile of TV-46000 for the treatment of schizophrenia.
Among patients with schizophrenia, TV-46000 had a favorable safety profile that was consistent with other formulations of risperidone and previous studies of TV-46000, according to a study published in CNS Drugs.
As Healio previously reported, the FDA approved TV-46000 (Uzedy; Teva Pharmaceuticals, MedinCell), a long-acting subcutaneous risperidone injection, in April 2023 for the treatment of schizophrenia in adults.
“The confirmatory research reinforces Uzedy as a safe and effective long-acting treatment option for people living with schizophrenia, including African Americans who, compared to white Americans, receive less often newer and more efficacious or standard-of-care antipsychotics,” Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine in Hempstead, New York, told Healio.
To evaluate the long-term safety, tolerability and exposure of TV-46000 among patients with schizophrenia, Correll and colleagues conducted the SHINE study, a multicenter, double-blind, parallel-group study of 336 patients aged 16 to 67 years (median age, 54 years; 64% male; 54% Black/African American) with stable schizophrenia who completed the RISE study without relapse or were newly recruited.
The researchers randomly assigned patients who received placebo in the RISE study and patients who were newly recruited in a 1:1 ratio to receive TV-46000 once monthly (50-125 mg; n = 172) or once every 2 months (100-250 mg; n = 162) for up to 56 weeks.
The primary endpoint of the study was the frequency of reported adverse events.
Overall, 334 patients were evaluated for safety. Of those who received TV-46000 once monthly, 37% had at least one adverse event and 21% had at least one treatment-related adverse event. Of those who received TV-46000 once every 2 months, 46% had at least one adverse event and 20% had at least one treatment-related adverse event.
The researchers found that injection site pain and injection site nodule were frequent treatment-related adverse events. Most adverse events related to injection site reactions were mild or moderate.
Serious adverse events were reported in 5% of patients who received TV-46000 once monthly and 7% of those who received TV-46000 once every 2 months. Serious adverse events reported by two or more patients included worsening schizophrenia and hyperglycemia, according to the researchers.
Additionally, a greater proportion of patients without prior TV-46000 treatment experienced adverse events (49% vs. 34%) and serious adverse events (9% vs. 3%) compared with those with prior TV-46000 treatment.
“These results provide longer-term safety data confirming the favorable profile of Uzedy for the treatment of schizophrenia, with African Americans representing 54% of enrolled patients,” Correll said. “This is significant because historically, minorities have been less well represented in major clinical trials.”
Correll and colleagues acknowledged several study limitations, including low adolescent participation.
“Future studies aiming for the inclusion of adolescents should target specialized child and adolescent psychiatry departments who treat a substantial number of adolescent patients with schizophrenia to achieve a reasonable chance of enrolling a meaningful number of adolescents,” the researchers wrote.
For more information:
Christoph Correll, MD, can be reached at ccorrell@northwell.edu.