Nuplazid (pimavanserin) filed with FDA for psychosis in Parkinson�s disease- Acadia Pharma

Acadia Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA seeking approval for Nuplazid (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease.

NDA submission is based on data from a comprehensive development programme assessing the safety and efficacy of pimavanserin for Parkinson’s disease psychosis. The NDA includes data from the pivotal Phase III -020 Study, in which pimavanserin met all primary and secondary endpoints with statistical significance, along with supportive data from other studies with pimavanserin. The -020 Study demonstrated that pimavanserin significantly reduced psychosis compared to placebo in patients with Parkinson’s disease psychosis with no worsening of motor function. These results were further supported by significant improvements in all secondary efficacy measures and by significant benefits in exploratory efficacy measures of nighttime sleep, daytime wakefulness and caregiver burden. Consistent with previous studies, pimavanserin was safe and well tolerated in the -020 Study. Detailed results of the -020 Study have been published in The Lancet.