Aripiprazole lauroxil appears to improve schizophrenia symptoms safely, significantly

Aripiprazole lauroxil offered safe and clinically significant symptom improvement for patients with schizophrenia, according to study results published in Journal of Clinical Psychiatry.

“Aripiprazole lauroxil is an atypical long-acting antipsychotic for intramuscular injection that was developed as a prodrug of aripiprazole and approved for the treatment of schizophrenia in adults,” John Lauriello, MD, of the department of psychiatry and human behavior at Thomas Jefferson University in Philadelphia, and colleagues wrote. “The efficacy, safety and tolerability of [aripiprazole lauroxil] 441 mg or 882 mg every 4 weeks for the treatment of schizophrenia were demonstrated in a 12-week phase 3 randomized, double-blind, placebo-controlled trial. The adverse event profile associated with [aripiprazole lauroxil] in that 12-week study was consistent with that observed with oral aripiprazole at doses indicated for schizophrenia (10–30 mg/d).”

Moreover, results of a 52-week outpatient study that evaluated safety of apiprazole lauroxil among patients with stable schizophrenia showed a similar safety profile to that observed in the acute, 12-week study.

In the current extension study of the analysis of an extension study of the 52-week safety study, Lauriello and colleagues aimed to examine the long-term safety, tolerability and symptom trajectory of aripiprazole lauroxil among patients with schizophrenia according to DSM-5 diagnosis who were followed for up to 3.5 years. They analyzed long-term safety data gathered during the two sequential long-term safety studies and looked specifically at adverse events, adverse events leading to study discontinuations, physical examinations, laboratory parameters and extrapyramidal symptom rating scales as safety metrics. Further, they used Positive and Negative Syndrome Scale total (PANSS_T) and Clinical Global Impressions-Severity of Illness scale (CGI-S) scores in post hoc analyses to assess symptom trajectory.

Safety analysis data of 478 patients were available. Safety assessments after the first 42 weeks showed no new safety concerns and were consistent with aripiprazole’s established safety profile. A total of 57.5% of patients reported adverse events, and extrapyramidal symptom-related adverse events occurred among 12.8% of patients. The post hoc analysis of data of 432 patients revealed least-squares mean PANSS_T scores improved significantly from 12 weeks to 124 weeks with aripiprazole lauroxil 441 mg and 882 mg (both, P < .0001). The researchers observed a similar pattern of improvement in CGI-S scores.

“No unexpected safety concerns were identified during the 180-week (3.5-year) follow-up period,” Lauriello and colleagues wrote. “Continuous efficacy data examined post hoc demonstrated that schizophrenia symptoms and severity of illness improved over the course of the 112-week study period, with no apparent dose effect. Results of this analysis demonstrate the tolerability and continued therapeutic efficacy of long-term treatment with [aripiprazole lauroxil] 441 mg and 882 mg given every 4 weeks in adult patients with schizophrenia.”