Data from Phase III trial of ALKS 9070 (aripiprazole lauroxil) for schizophrenia published in J Clinical Psychiatry- Alkermes

Alkermes has announced the publication of results from its Phase III clinical trial of ALKS 9070 (aripiprazole lauroxil) for the treatment of schizophrenia in the Journal of Clinical Psychiatry. Data from the trial showed that multiple dose strengths of aripiprazole lauroxil administered once monthly demonstrated statistically significant reductions in schizophrenia symptoms, compared to placebo.

Patients treated once monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at Week 12, compared to placebo. The improvement from baseline to Week 12 in PANSS total scores was clinically meaningful and statistically significant in both aripiprazole lauroxil dose groups, with a placebo-adjusted mean PANSS score reduction of 10.9 points for the 441 mg dose group and 11.9 points for the 882 mg dose group. In addition to meeting the prespecified primary efficacy endpoint of PANSS total score reduction, 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.

Results of the study served as the basis for Alkermes’ New Drug Application to the FDA to gain marketing approval of aripiprazole lauroxil for the treatment of schizophrenia, with a regulatory action date of Aug. 22, 2015.