==Acadia Pharmaceuticals (ACAD) : schizophrenia drug study falls short

 

Pharmaceuticals announces top-line results from the Phase 3 ADVANCE-2 trial evaluating pimavanserin for the treatment of negative symptoms of schizophrenia 

• Pimavanserin did not demonstrate a statistically significant improvement over placebo on the study's primary endpoint, the change from baseline to week 26 on the Negative Symptom Assessment-16 (NSA-16) total score (-11.8 vs. -11.1; p=0.4825; effect size=0.07). The safety and tolerability profile of pimavanserin was consistent with previous clinical trials, showing a low rate of adverse events.
• "We are disappointed the trial did not meet its primary endpoint given the significant unmet need in patients with negative symptoms of schizophrenia," said Steve Davis, Acadia's Chief Executive Officer. "We will continue to analyze these data with our scientific advisors, but we do not intend to conduct any further clinical trials with pimavanserin. We want to thank the patients, their families, and the investigators for their contributions in this important study."