“We are excited with the results of this study which demonstrate that pimavanserin has the potential to offer PDP patients a new treatment option that, for the first time, can achieve the desired clinical profile by providing an effective, safe and well tolerated antipsychotic therapy,” said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. “We remain committed to advancing pimavanserin to registration as a first-in-class treatment for this large unmet medical need. These results also suggest that pimavanserin may have the ideal clinical profile to address a broader range of neuropsychiatric disorders that are underserved by currently marketed antipsychotics.”
“These significant and consistent top-line results are a strong validation of the optimized study design used in this trial,” said Roger G. Mills, M.D., ACADIA’s Executive Vice President of Development. “Encouragingly, benefits of pimavanserin were seen by patients, caregivers and investigators, as well as the independent raters. Following the successful outcome of this pivotal Phase III trial, we will continue our ongoing preparations for a confirmatory pivotal Phase III trial, the -021 Study, using the same trial design.”
About the Trial Design
The pivotal Phase III trial, referred to as the -020 Study, was a multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy, tolerability and safety of pimavanserin as a treatment for patients with PDP. A total of 199 patients were enrolled in the study and randomized on a one-to-one basis to receive either 40 mg of pimavanserin or placebo once-daily for six weeks, following a two-week screening period including brief psycho-social therapy. Patients also received stable doses of their existing anti-Parkinson’s therapy throughout the study. The primary endpoint of the -020 Study was antipsychotic efficacy as measured using the “SAPS–PD” scale, which consists of nine items from the hallucinations and delusions domains of the Scale for the Assessment of Positive Symptoms, or SAPS. These nine items have been shown to be particularly relevant to the expression of psychotic symptoms in patients with Parkinson’s disease and to have high inter-rater reliability for assessment of severity. Motoric tolerability was a key secondary endpoint in the study and was measured using Parts II and III of the Unified Parkinson’s Disease Rating Scale, or UPDRS.