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US approves first drug for psychosis linked to Parkinson’s

May 3, 2016

A new drug that aims to treat a serious symptom of Parkinson’s disease been approved by the US Food and Drug Administration, and could be coming to the UK soon.

The drug from Acadia Pharmaceuticals Inc. is the first drug for the condition, which affects approximately half of Parkinson’s patients.

Parkinson’s disease is a neurodegenerative disorder characterized by motor symptoms such as shaking in the hands and legs as well as stiffness and impaired balance.

But as many as half of those with Parkinson’s are estimated to experience psychosis symptoms as well.

Nuplazid was used in a 199-participant, six-week clinical trial, which proved the drug’s effectiveness. Of the 199, about half were given Nuplazid in addition to any other Parkinson’s treatment they were already using, while the rest were given a placebo. None of the participants were allowed to take any other form of antipsychotic.

Against a placebo drug, Nuplazid was able to reduce the severity or frequency, or both, of the episodes wherein the Parkinson’s disease patient suffers from delusions and hallucinations. Notably, the drug does not worsen the disease’s primary motor symptoms.

“Today’s approval of Nuplazid represents a major paradigm shift in the treatment of Parkinson’s disease psychosis,” said Michael Okun, 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.”

“Nuplazid was shown to be superior to placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinson’s disease,” the FDA said in a release after its approval of the drug.

The company is planning to seek approval for the drug in Europe in the next few months.


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