J&J presents encouraging data from risperidone injection trail

This 24-month, open-label, active-controlled, comparative international study, was the largest since the 1979 Hogarty study to compare the relapse rates of a long-acting injectable antipsychotic and an oral medication. The objective of the trial was to compare longer-term maintenance therapy of patients with schizophrenia or other related disorders (schizoaffective disorder) treated with risperidone long-acting injection (RLAI) or quetiapine. The study was sponsored by Janssen-Cilag, Medical Affairs EMEA.

Results demonstrated that the average relapse-free time was significantly longer in patients treated with RLAI (607 days) compared with quetiapine (533 days), p<0.0001. Furthermore, over the 24-month treatment period, relapse occurred in 16.5% of patients treated with RLAI and 31.3% in the quetiapine treatment arm. Separately, an interim analysis from a two-year US observational study also showed patients taking RLAI had significantly improved functioning within three months after starting treatment. That study enrolled 532 patients from 66 community health centers and Veterans Affairs centers in the US. Data collection occurred at baseline (month 0) and then every three months up to the two years. At the time of this interim analysis, 107 patients had completed the full two-year period. The US interim analysis showed an overall significant improvement in patient functioning from serious to occasional impairments following initiation of RLAI (p<0.001), and 11% more patients reported they were 'very' or 'extremely' satisfied with their current antipsychotic therapy at the first visit after the initiation of treatment with RLAI compared to their first visit prior to the initiation of RLAI. The study was sponsored by Ortho-McNeil Janssen Scientific Affairs.