Aripiprazole lauroxil (AL) and paliperidone palmitate (PP) are effective and well tolerated for initiating treatment of schizophrenia in the hospital and for continuing outpatient treatment, results of a phase 3, double-blind trial show.
A total of 200 patients completed the study, 99 of whom received aripiprazole lauroxil (Aristada Initio) and 101 of whom received paliperidone palmitate (Invega Sustenna). The baseline Positive and Negative Syndrome scale (PANSS) total score for those who received aripiprazole lauroxil was 94.1 and 94.6 for those who received paliperidone palmitate, Peter J. Weiden, MD, of Alkermes, and his associates reported in the Journal of Clinical Psychiatry.
After 4 weeks of treatment, patients who received aripiprazole lauroxil saw a mean PANSS score reduction of 17.4 points; after 9 weeks the reduction was 19.8 points and was 23.3 points after 25 weeks. For patients who received paliperidone palmitate the reduction in PANSS score was 20.1 points at week 4, 22.5 points at week 9, and 21.7 points at week 25. The most common adverse events in both groups were injection-site pain (17.2% and 24.8%, respectively), increased weight (9.1% and 16.8%, respectively), and akathisia (9.1% and 10.9%, respectively).
“Acutely symptomatic patients with schizophrenia on a 2-month dose regimen of AL with the 1-day initiation regimen demonstrated safety and efficacy consistent with that seen in prior AL studies. ... The inclusion of PP provided an active control with known safety and efficacy that can also be rapidly initiated. the investigators concluded.
The study was sponsored by Alkermes, manufacturer of Aristada Initio. Invega Sustenna is produced by Janssen Pharmaceuticals. The investigators reported being employed by, owning stock/options in, or receiving research support from Alkermes; two investigators reported receiving research support from numerous other companies.
SOURCE: Weiden PJ et al. J Clin Psychiatry. 2020 May 19. doi: 10.4088/JCP.19m13207.