Acadia announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Nuplazid (pimavanserin) for Priority Review.  

The company is currently seeking approval for Nuplazid in the treatment of psychosis associated with Parkinson’s disease. The NDA submission is based on data from a Phase 3 -020 Study, in which Nuplazid showed statistical improvement on all primary and secondary efficacy endpoints with no worsening of motor function.

RELATED: Nuplazid NDA Submitted for Parkinson’s Disease Psychosis

Nuplazid is a proprietary selective serotonin inverse agonist (SSIA, a new class of non-dopaminergic antipsychotics that target the 5-HT2A receptors. 

Nuplazid was granted Breakthrough Therapy designation for Parkinson’s disease psychosis in 2014. The target action date under the Prescription Drug User Fee Act has been set for May 1, 2016.

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