Phase III results from the latest trial of once-monthly aripiprazole intramuscular (IM) depot formulation show that positive symptoms develop at least one tenth less with aripiprazole treatment than placebo, over 52 weeks.
Lundbeck and Otsuka yesterday announced at the 165th Annual Meeting of the American Psychiatric Association (APA) in Philadelphia, USA, results from a clinical Phase III clinical trial evaluating the efficacy, safety and tolerability of once-monthly aripiprazole IM depot formulation for the maintenance treatment of adults with schizophrenia.
Trial results were presented in four poster presentations.
In a 52-week, double-blind, randomised, placebo-controlled study, aripiprazole IM depot significantly delayed time-to-impending relapse compared with placebo, the primary endpoint of the study (Hazard ratio = 5.03, p<0.0001).
In addition, improvements in the symptoms [as measured by the Positive and Negative Syndrome Scale (PANSS) total score] were maintained throughout the study in patients treated with aripiprazole IM depot formulation, while patients who received placebo reported significantly worsening scores (mean change from baseline at week 52 was 1.4 for aripiprazole IM depot compared with 11.6 for placebo; LOCF analysis, p<0.0001).
Results also demonstrated that aripiprazole IM depot was well tolerated, with a discontinuation rate due to treatment-related adverse events less than placebo (7.1% vs. 13.4%, respectively).
A more specific look at the effectiveness results shows that, during the maintenance treatment phase, PANSS subscale scores showed both positive and negative symptom stability with aripiprazole IM depot while showing significant worsening for patients who received placebo [mean change from baseline in PANSS positive symptom subscale scores was 0.4 for aripiprazole IM depot compared to a mean change of 4.3 for placebo (LOCF analysis, p<0.0001); and a mean change in baseline of 0.2 vs. 1.6 for PANSS negative subscale scores (LOCF analysis, p<0.0001)].
In addition, mean change from baseline in PSP scale scores during the maintenance treatment phase of the study showed greater stability of social functioning with aripiprazole IM depot compared to placebo (-1.7 vs. -6.2, respectively; LOCF analysis, p=0.0002).
Also, mean change from baseline in the IAQ (a 12-item assessment of overall effectiveness) total scores also remained more stable amongst patients who received aripiprazole IM depot than those receiving placebo during the maintenance treatment phase (mean change was +1.3 for aripiprazole IM depot vs. +3.8 for placebo; LOCF analysis, p<0.0001).
“Otsuka and Lundbeck are committed to advancing care and addressing unmet needs for patients with schizophrenia,” said William H. Carson, M.D., President and CEO, Otsuka Pharmaceutical Development & Commercialization, Inc. “We are pleased to report on the positive data from the pivotal Phase 3 study designed to evaluate the efficacy and tolerability of aripiprazole IM depot as a long-term maintenance treatment for patients with schizophrenia.”.
“We are very encouraged by these data of aripiprazole IM depot formulation which shows that a once-monthly injection of this compound is effective in delaying the time to relapse for patients with schizophrenia” says Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck, and continues: “As relapsed patients experience further erosion of his or her mental and overall physical health, which again can lead to decreased functioning, increased morbidity and thereby worsen the overall outcome.“