Dainippon Sumitomo Reports Positive PEARL 2 Results

Dainippon Sumitomo Pharma has reported positive results from PEARL 2, a phase 3 clinical trial of lurasidone for the treatment of patients with schizophrenia. In the trial, both lurasidone 40 and 120mg/day were more effective than placebo for the treatment of schizophrenia. Lurasidone was well-tolerated with an overall discontinuation rate that was similar to placebo.

The PEARL 2 study was a double-blind, fixed-dose, placebo-controlled clinical trial involving 478 inpatients with acute schizophrenia, that were randomised to receive either lurasidone 40 or 120mg/day, olanzapine 15mg/day or placebo for six weeks.

Lurasidone 40 and 120mg, taken once-daily, reportedly demonstrated greater improvement versus placebo on the primary efficacy measure, the Positive and Negative Syndrome Scale (PANSS) total score, at study endpoint.

A total of 53% of patients on lurasidone 40mg/day and 47% of patients on lurasidone 120mg/day demonstrated a 30% or more improvement on the PANSS total score from baseline, versus 38% on placebo.

In addition, both lurasidone dose groups were more effective than placebo on the Clinical Global Impressions Severity scale (CGI-S), the key secondary efficacy endpoint. The CGI-S score changes from baseline for lurasidone 40 and 120mg/day versus placebo were -1.5 and -1.4 vs. -1.1, respectively, at study endpoint.

Olanzapine 15mg/day produced greater improvements than placebo on both the PANSS total score (-28.7 vs. -16.0 placebo) and CGI-S (-1.5 vs. -1.1 placebo). A total of 64% of patients on olanzapine demonstrated a 30% or more improvement on the PANSS total score from baseline versus 38% on placebo.