Promising data from a phase III study of aripiprazole lauroxil (Alkermes LLC), an investigational drug candidate in development for the treatment of schizophrenia, have been presented at the American Society of Clinical Psychopharmacology (ASCP) annual meeting in Hollywood, Florida.
In the pivotal trial, both doses of aripiprazole lauroxil (441 mg and 882 mg), administered once-monthly, met the primary endpoint, achieving statistically significant reductions in Positive and Negative Syndrome Scale (PANSS) scores compared with placebo. The study also met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms with aripiprazole lauroxil.
A new drug application is expected to be submitted to the FDA in the third quarter of 2014.
In the trial, 623 patients with acute exacerbation of schizophrenia were randomly assigned to receive once-monthly intramuscular injections of aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg, or matching placebo for 12 weeks. After randomization, patients received their first injection along with daily oral study drug for the first 3 weeks.
Patients assigned to the two aripiprazole lauroxil treatment groups received oral aripiprazole for those initial 3 weeks, whereas patients assigned to the placebo group received matching oral placebo for 3 weeks. A total of 596 patients were included in the full analysis set, defined as those who received at least one dose of study drug and had at least one primary efficacy assessment after the administration of study drug.
During the 12-week, double-blind treatment period, the patients treated once monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically and clinically significant placebo-adjusted mean reductions from baseline in PANSS total scores (–10.9 points, P < 0.001 for aripiprazole lauroxil 441 mg; and –11.9 points, P < 0.001 for aripiprazole lauroxil 882 mg).
In addition to meeting its prespecified primary efficacy endpoint, the study also met the prespecified key secondary endpoint of improvement on the Clinical Global Impression—Improvement (CGI-I) scale for each aripiprazole lauroxil group versus placebo at week 12 (P < 0.001).
Both of the aripiprazole lauroxil dosing groups demonstrated significant improvement at all post-baseline visits. In addition, all other secondary endpoints were found to be statistically significant across both doses.
The most common adverse events associated with the active treatment were insomnia, akathisia, and headache.