ACAD DATA: Statistically significant benefits and improvements with Acadia drug. POSTED
Yahoo In:Play 3/21/13
1:29AM ACADIA Pharmaceuticals presents data from its pivotal Phase III Parkinson's Disease psychosis study with Pimavanserin (ACAD) 6.65 : Co detailes results today from ACADIA's pivotal Phase III -020 Study with pimavanserin in patients with Parkinson's disease psychosis. Pimavanserin met the primary endpoint in the -020 Study by demonstrating highly significant antipsychotic efficacy on the 9-item SAPS-PD scale. Pimavanserin also met the key secondary endpoint for motoric tolerability as measured using Parts II and III of the Unified Parkinson's Disease Rating Scale, or UPDRS. The new data from the -020 Study showed highly significant improvements in all secondary efficacy measures, including the Clinical Global Impression Severity, or CGI-S, scale, the Clinical Global Impression Improvement, or CGI-I, scale, and a CGI-I responder analyses. The CGI-I responder results showed that approximately twice as many subjects in the pimavanserin treatment arm, as compared to placebo, were rated as very much improved or much improved at the conclusion of the study. In addition, pimavanserin demonstrated significant improvements using the full 20-item SAPS scale and each of the separate hallucinations and delusions domains insupportive analyses. Statistically significant benefits were also observed in exploratory measures of nighttime sleep, daytime wakefulness, and caregiver burden.