Positive data for Abilify Maintena in Schizophrenia-Otsuka/Lundbeck

Otsuka America Pharmaceutical and Lundbeck announced results from the QUALIFY study, the first study of its kind comparing the effectiveness of aripiprazole once-monthly Abilify Maintena (aripiprazole extended-release injectable suspension) and paliperidone palmitate in adult patients with Schizophrenia. Results were measured by the Heinrichs-Carpenter Quality of Life Scale (QLS; primary endpoint). In a 28 week trial, patients treated with aripiprazole once-monthly demonstrated a statistically significant and superior improvement in the QLS total score compared to those treated with paliperidone palmitate.

The mean difference between treatments of the change from baseline to week 28 in QLS total score was 4.4 with a respective change of 7.5 for the aripiprazole once-monthly group and 3.1 for the paliperidone palmitate group. A difference between treatments was also confirmed by a change in the Clinical Global Impression-Severity Scale (CGI-S, used by clinicians to evaluate the overall severity of a patient’s illness). Both treatments were generally well-tolerated, however discontinuation rates due to adverse events were 10.8% (n=16/148) vs. 18.4% (n=27/147), for aripiprazole once-monthly group vs paliperidone once-monthly group, respectively.