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| Image: Nuplazid is an oral medicine taken once a day with a recommended dose of 34 mg (two 17 mg tablets). Photo: courtesy of Business Wire. |
Acadia Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Parkinson’s disease psychosis.
The regulator has however asked Acadia to include a boxed warning on the drug's label for an increased risk of death associated with its use in older people.
The approval was based on data from the pivotal phase III study -020 and other trials, which supported the use of Nuplazid.
In study -020, the drug reduced the frequency and severity of psychotic symptoms compared to placebo on the scale for assessment of positive symptoms - Parkinson's disease.
FDA center for drug evaluation and research director of the division of psychiatry products Mitchell Mathis said: "Hallucinations and delusions can be profoundly disturbing and disabling.
"Nuplazid represents an important treatment for people with Parkinson's disease who experience these symptoms."
Nuplazid is a non-dopaminergic, selective serotonin inverse agonist preferentially targeting 5-HT2A receptors that are believed to play a key role in Parkinson's disease psychosis.
It is an oral medicine taken once a day with a recommended dose of 34 mg (two 17 mg tablets).
Nuplazid's pharmacology establishes a new class of drug - selective serotonin inverse agonists (SSIA) - by preventing activity at dopamine and other receptors commonly targeted by antipsychotics.
According to the National Parkinson Foundation, about one million people in the US suffer from Parkinson's disease and an estimated 50,000 Americans are diagnosed with the disease every year.
http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-approves-acadias-nuplazid-to-treat-parkinsons-disease-psychosis-020516-4879858
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