Nuplazid Designated Breakthrough Therapy for Parkinson's Disease Psychosis

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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