Drug for Parkinson’s-related psychosis approved in US

The first drug to treat the common problem of hallucinations and delusions caused by Parkinson’s disease, has been approved by the US Food and Drug Administration.

Nuplazid (pimavanserin) has been developed by US pharma company Acadia, and was designated a Breakthrough Therapy by the US drug regulator in 2014, and will now be launched in June.

The drug uses an ingenious mechanism to treat the psychosis symptoms, which affects up to 50% of patients with Parkinson’s disease.

Nuplazid is the first in a new class of drug – selective serotonin inverse agonists (SSIA) – and unlike existing antipsychotic drugs, doesn’t worsening the debilitating shaking and tremor seen in people with Parkinson’s.

“Today’s approval of Nuplazid represents a major paradigm shift in the treatment of Parkinson’s disease psychosis,” said Michael S. Okun, M.D., Medical Director of The National Parkinson Foundation. “Through its novel and selective mechanism of action, Nuplazid is a breakthrough treatment that works in a whole new way – treating hallucinations and delusions without blocking dopamine receptors and, therefore, not impairing motor function in Parkinson’s psychosis patients.”

Acadia already has the drug in phase 2 trials as an antipsychotic for Alzheimer’s disease, which if it gains approval, would help it break through the $1 billion annual sales mark.

Evaluate Pharma recently forecast 2020 sales of $841 million for Nuplazid, while Thompson Reuters’ annual Drugs to Watch study predicted $1.4 billion within the same period.

The San-Diego based pharma company is also planning a clinical study with pimavanserin as a monotherapy for the maintenance phase of schizophrenia.

Steve Davis, President and CEO of Acadia has said the company would submit Nuplazid to Europe’s regulator after the FDA’s decision.

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