In the phase 3 RISE study, researchers evaluated TV-46000, a long-acting subcutaneous antipsychotic, in patients with schizophrenia. The long-term safety of TV-46000 was then assessed in the SHINE study, which included both RISE participants and newly recruited patients. Pooled results for the trials were presented at the American Psychiatric Association 2023 Annual Meeting by John Michael Kane, MD.
Compared with placebo, TV-46000 significantly increased time to impending relapse by 5.0 times and 2.7 times when administered once monthly or once every two months, respectively, in patients with schizophrenia. Additionally, TV-46000 demonstrated a risk-benefit profile similar to other formulations of risperidone, according to Dr. Kane and colleagues.
The RISE study randomized 544 patients to TV-46000 once monthly, once every two months, or placebo. Researchers found TV-46000 once monthly (hazard ratio [HR], 0.2; 95% CI, 0.109-0.367; P<.0001) and once every two months (HR, 0.375; 95% CI, 0.227-0.618; P<.0001) significantly improved time to relapse versus placebo, with relative risk of relapse decreases of 80.0% and 62.5%, respectively. The estimated number of patients relapse-free at week 24 was 0.93 for the once-monthly group and 0.89 for the once-every-two-months group.
Following RISE, the SHINE study enrolled 109 new patients with schizophrenia and 225 rollover participants from RISE, 172 from the TV-46000 once-monthly group and 162 from the once-every-two-months group. Researchers reported pooled safety data from both studies (n=525).
A total of three patients in each treatment group experienced relapse during SHINE. Researchers estimated 0.98 and 0.88 patients remained relapse-free by week 56 in the once-monthly and once-every-two-months groups, respectively.
Overall, general disorders and administration site conditions (52.89%) had the highest exposure-adjusted event rate, followed by nervous system disorders (34.34%). The most common events reported for these classes were injection site reaction and headache, akathisia, extrapyramidal disorder, dizziness, and somnolence.
Given their results in the RISE and SHINE trials, Dr. Kane and colleagues supported the efficacy and safety of TV-46000, a novel, long-acting, injectable formulation of risperidone, for the treatment of patients with schizophrenia.
