The results of a phase 3B study show the medication is effective treating the disorder despite only needing to be taken once every 8 weeks.
Recently, stakeholders announced positive data on a new schizophrenia treatment following a phase 3B clinical trial.
Alkermes published data in the Journal of Clinical Psychiatry from the six-month ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness) study, showing that aripiprazole lauroxil (ARISTADA INITIO) one-day initiation regimen, consisting of the treatment combined with a single dose of 30 mg oral aripiprazole, along with a two-month dose of aripiprazole lauroxil was effective for patients experiencing an acute exacerbation of schizophrenia.
In the multi-center, randomized, double-blind trial, investigators examined the efficacy and safety of the treatment regimen compared to paliperidone palmitate in hospitalized schizophrenia patients and continued treatment as individuals transitioned to outpatient care for ongoing continuation phase therapy.
The investigators sought outcomes of Positive and Negative Syndrome Scale (PANSS) total scores at week 4, week 9, and week 25.
For the intended treatment group, the mean baseline PANSST was 94.1 and scores were significantly reduced from baseline at week 4 (−17.4; P < .001), as well as at weeks 9 (−19.8) and 25 (−23.3).
In an interview with HCPLive®, Jelena Kunovac, MD, MS, Chief Medical Officer, Altea Research, explained how the positive results could ultimately improve care for treating a notoriously difficult to treat patient population.