Nuplazid Approval History
- FDA approved: Yes (First approved April 29th, 2016)
- Brand name: Nuplazid
- Generic name: pimavanserin
- Dosage form: Tablets
- Company: Acadia Pharmaceuticals, Inc.
- Treatment for: Parkinson’s Disease Psychosis
Nuplazid (pimavanserin) is a non-dopaminergic, selective serotonin inverse agonist (SSIA) for the treatment of psychosis associated with Parkinson’s disease.
The FDA approval of Nuplazid was based on data from the pivotal Phase III -020 Study, which demonstrated significant reduction in the frequency and severity of psychotic symptoms compared to placebo, without worsening the primary motor symptoms of Parkinson's disease.
The recommended dose of Nuplazid is two 17 mg tablets taken once daily with or without food.
Most common side effects reported during clinical trials include peripheral edema and confusional state.
Development History and FDA Approval Process for Nuplazid
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