NEW ORLEANS — Alkermes announced favorable Phase 4 clinical data showing that switching therapy to Aristada (aripiprazole lauroxil) extended-release injectable suspension resulted in statistically significant and clinically meaningful improvement in schizophrenia symptoms at the end of the study in patients who had inadequate response or intolerance to Invega Sustenna (paliperidone palmitate). The full findings were presented at the 30th Annual Psych Congress, in New Orleans, LA.
The 6-month, open-label, single-arm, prospective study (n=50) aimed to examine the safety, efficacy, and tolerability of Aristada in symptomatic, clinically stable patients with schizophrenia who had an inadequate response or intolerance to Invega Sustenna. Study patients had received ≥3 consecutive doses of Invega Sustenna before screening. The main reason for discontinuing Invega Sustenna was cited as insufficient control of positive symptoms (66%).
The data showed Aristada 441mg, 662mg given monthly or 882mg given every 6 weeks led to significant improvement in schizophrenia symptoms at 6 months; improvement was measured by the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity (CGI-S) scale. There was a decrease in the mean BPRS total score 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. Psychotic disorders, anxiety, and suicidal ideation were the most commonly reported adverse events.
Steven Potkin, MD, Professor Emeritus of Psychiatry and Human Behavior at the University of California, Irvine, stated, “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.”
Aristada, an atypical antipsychotic, is available as 6-week, 1-month, and 2-month dosing options for the treatment of schizophrenia.
- Potkin, S. Switching Patients With Schizophrenia From Paliperidone Palmitate to Aripiprazole Lauroxil: A 6-month Prospective Open-Label Study. Poster presented at Psych Congress; September 16–19, 2017; New Orleans, LA. http://www.psychcongress.com/psychcongress/
- Patients switched to alkermes’ ARISTADA® showed significant improvement in schizophrenia symptoms after inadequate response or intolerance to INVEGA SUSTENNA® [press release]. Dublin: Alkermes. http://phx.corporate-ir.net/phoenix.zhtml?c=92211&p=irol-corporateNewsArticle&ID=2301153. Published September 18, 2017. Accessed September 20, 2017.
This article originally appeared on MPR