Acadia Pharmaceuticals announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Nuplazid (pimavanserin) for the treatment of Parkinson’s disease psychosis. Nuplazid is a once daily, orally administered selective serotonin inverse agonist that preferentially targets 5-HT2A receptors.

Acadia has previously reported positive Phase 3 trial results for Nuplazid, which has the potential to be the first drug approved in the U.S. for psychosis associated with Parkinson’s disease.

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Acadia plans to submit a New Drug Application (NDA) for Nuplazid near the end of this year. The submission will be based on a completed Phase 3 trial in Parkinson’s disease psychosis and supportive data from other studies. Nuplazid is also in Phase 2 development for Alzheimer’s disease psychosis and has successfully completed a Phase 2 trial in schizophrenia.

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