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news.The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for ACADIA Pharmaceuticals' Nuplazid (pimavanserin), a selective serotonin inverse agonist, to treat Parkinson’s disease psychosis.
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If approved, Nuplazid will establish a new and distinctly different pharmacological approach to treat psychosis.
The company has already completed a pivotal Phase III trial of Nuplazid in Parkinson’s disease psychosis, which the FDA has agreed can serve as the basis, together with supportive data from other studies, for a the submission of a new drug application (NDA).
National Parkinson Foundation president and chief executive officer Joyce Oberdorf said the hallucinations and delusions in Parkinson’s disease psychosis are devastating to patients and contribute to a dramatic rise in caregiver burden.
"Parkinson’s disease psychosis is a leading cause of nursing home placement for Parkinson’s patients and, with no FDA-approved therapy for this serious condition, there is a great unmet medical need for an effective, safe, and well-tolerated treatment option for patients," Oberdorf said.
The company intends to submit NDA for Nuplazid to FDA at the end of this year.
ACADIA chief executive officer Uli Hacksell said the Breakthrough Therapy status for Nuplazid strengthens the urgent need for a treatment for patients with Parkinson’s disease psychosis.
"NUPLAZID represents a potential new class of psychosis medication and could be the first drug approved in the United States for patients with Parkinson’s disease psychosis," Hacksell said.