Acadia announced results from its pivotal Phase 3 -020 Study with pimavanserin in patients with Parkinson’s disease psychosis (PDP). Pimavanserin acts selectively as an antagonist/inverse agonist on serotonin 5-HT2A receptors.
The -020 Study was a multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy, tolerability and safety of pimavanserin. A total of 199 participants were randomized 1:1 to receive either pimavanserin 40mg 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 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 (SAPS).
Pimavanserin met the primary endpoint by demonstrating significant improvement in psychosis compared to placebo on the 9-item SAPS-PD scale (P=0.001). The mean change in SAPS-PD score represented a 37% improvement for pimavanserin vs. 14% for placebo (P<0.001). Pimavanserin also demonstrated significant improvement on the full 20-item SAPS (hallucinations plus delusions) measure (P=0.001) and on each of the separate hallucinations and delusions domains in supportive analyses.
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