FDA approves Acadia’s Nuplazid to treat Parkinson’s disease psychosis

PBR Staff Writer

Published 02 May 2016

Image: Nuplazid is ~y oral medicine taken once a light of ~ with a recommended dose of 34 mg (couple 17 mg tablets). Photo: courtesy of Business Wire.

Acadia Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) despite Nuplazid (pimavanserin) to treat hallucinations and delusions associated by Parkinson’s disease psychosis.

The regulator has notwithstanding asked Acadia to include a boxed omen on the drug’s label notwithstanding an increased risk of death associated by its use in older people.

The approval was based in c~tinuance data from the pivotal phase III study -020 and other trials, what one. supported the use of Nuplazid.

In study -020, the deaden with narcotics reduced the frequency and severity of psychotic symptoms compared to placebo in successi~ the scale for assessment of indisputable symptoms – Parkinson’s disease.

FDA center in favor of drug evaluation and research director of the disunion of psychiatry products Mitchell Mathis before-mentioned: “Hallucinations and delusions can be profoundly disturbing and disabling.

“Nuplazid represents some important treatment for people with Parkinson’s ail who experience these symptoms.”

Nuplazid is a non-dopaminergic, selective serotonin indirect agonist preferentially targeting 5-HT2A receptors that are believed to perform on a key role in Parkinson’s distemper psychosis.

It is an oral medicament taken once a day with a recommended dose of 34 mg (two 17 mg tablets).

Nuplazid’s pharmacology establishes a newly come class of drug – selective serotonin inverse agonists (SSIA) – by preventing activity at dopamine and other receptors commonly targeted ~ the agency of antipsychotics.

According to the National Parkinson Foundation, over one million people in the US feel pain from Parkinson’s disease and every estimated 50,000 Americans are diagnosed through the disease every year.

http://regulatoryaffairs.pharmaceutical-dealing-review.com/news/fda-approves-acadias-nuplazid-to-discuss-parkinsons-disease-psychosis-020516-4879858

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