The drug showed improved symptoms across multiple doses in a 6-month study.
Phase 4 study results have shown that switching treatment from paliperidone palmitate (INVEGA SUSTENNA) to aripiprazole lauroxil (ARISTADA) led to statistically significant and clinically meaningful improvement in schizophrenia symptoms, according to Alkermes plc, the manufacturer behind ARISTADA.
The company announced positive topline results of the phase 4 clinical trial September 18 at the 30th annual Psych Congress in New Orleans, Louisiana. Treatment with a flexible dose regimen of ARISTADA 441 mg, 662 mg, or 882 mg monthly, or 882 mg every 6 weeks, resulted in significant improvement in schizophrenia symptoms at 6 months, as measured by the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity (CGI-S) scale.
Mean BPRS total score decreased from 37.6 to 32.7 (p=0.002), and the mean CGI-S score decreased from 3.9 to 3.4 (p<0.001) between baseline and the 6-month endpoint, with 34 patients (68%) completing the 6-month study.
The most commonly reported adverse events were psychotic disorders, anxiety and suicidal ideation, according to Alkermes.
“The results from this study highlight the potential clinical benefits of switching to ARISTADA for patients who experience inadequate response or intolerance to INVEGA SUSTENNA, a medicine widely recognized in the clinical community as a powerful antipsychotic agent,” said Steven Potkin, MD, professor emeritus of psychiatry and human behavior at the University of California, Irvine. “Patients and their healthcare providers need options with different pharmacology when choosing a treatment regimen, and these data further support the use of ARISTADA in the treatment of schizophrenia.”
ARISTADA is an injectable atypical antipsychotic with one-month, 6-week and 2-month dosing options for the treatment of schizophrenia. Oral aripiprazole should be administered for 21 consecutive days in conjunction with the first injection of ARISTADA. Once in the body, the drug converts to aripiprazole. The drug was approved for a 2-month dosing option in early June.
The 6-month, open-label, single-arm phase 4 study tested the efficacy, safety and tolerability of ARISTADA in 50 symptomatic, clinically stable patients with schizophrenia who had an inadequate response or intolerance to INVEGA SUSTENNA.
Patients enrolled in the study had received at least 3 consecutive doses of INVEGA SUSTENNA before screening, with 50% of patients entering the study having received the highest dose of INVEGA SUSTENNA 234 mg. The primary reason for discontinuation was insufficient control of positive symptoms (n=33, 66%). 8 patients (16%) switched because of breakthrough negative symptoms, and 9 patients (18%) switched because they were intolerant to INVEGA SUSTENNA.
“These data further add to the substantial body of evidence supporting the differentiated efficacy and safety profile of ARISTADA in the treatment of this chronic and debilitating disease,” said Elliot Ehrich, MD, executive vice president, research and development, Alkermes. “Driven by scientific and economic outcomes data, the recognition of the benefits of long-acting atypical antipsychotics continues to grow within the medical community.