Aripiprazole lauroxil: Additional Phase III data

Additional data from a double-blind, international Phase III trial in 623 patients with acute exacerbation of schizophrenia showed that once-monthly intramuscular aripiprazole lauroxil led to placebo-adjusted mean reductions in PANSS total score from baseline to week 12, the primary endpoint, of 10.9 points at the 441 mg dose and of 11.9 points at the 882 mg dose (p<0.001 for both). Patients also received daily oral aripiprazole or placebo for the first 3 weeks of the trial. Patients are eligible to continue in an open-label, extension phase to receive once-monthly intramuscular aripiprazole lauroxil for an additional 12 months. Data were presented at the American Society of Clinical Psychopharmacology meeting in Hollywood. Alkermes previously reported that both doses of aripiprazole lauroxil met the primary endpoint of improving PANSS score vs. placebo. Both doses of aripiprazole lauroxil also met the secondary endpoint of improving CGI-I scores from baseline to week 12 vs. placebo (p<0.001 for both) (see BioCentury, April 14). ...