Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S announced results
from a Phase 3 clinical trial evaluating the efficacy, safety and
tolerability of once-monthly aripiprazole (see structure) intramuscular (IM) depot
formulation for the maintenance treatment of adults with schizophrenia.
Trial results were presented in four poster presentations at the 2012
American Psychiatric Association (APA) Annual Meeting in Philadelphia.
In a 52-week, double-blind, randomized, placebo-controlled study conducted by Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), aripiprazole IM depot formulation significantly delayed time-to-impending relapse compared to 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 formulation compared to 11.6 for placebo; LOCF analysis, p<0.0001).
“Long-term disease maintenance is the ultimate goal of treating the nearly 2.2 million adults living with schizophrenia in the U.S.,” said study investigator John M. Kane, M.D., Chairman of Psychiatry, The Zucker Hillside Hospital, and Vice President, Behavioral Health Services, North Shore-LIJ Health System. “Every relapse a patient experiences causes further erosion of his or her mental and physical health, which can lead to decreased functioning, increased isolation, increased morbidity and poorer overall outcomes. These study results demonstrate that a once-monthly injection of aripiprazole IM depot formulation is effective in delaying the time to relapse for patients with schizophrenia.”
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