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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

DateArticle
Apr 29, 2016Approval FDA Approves Nuplazid (pimavanserin) for Parkinson’s Disease Psychosis
Mar 29, 2016FDA Advisory Committee Votes 12 to 2 That Benefits of Nuplazid (Pimavanserin) for the Treatment of Psychosis Associated with Parkinson’s Disease Outweigh the Risks
Nov  2, 2015Acadia Pharmaceuticals Announces FDA Priority Review of Nuplazid (Pimavanserin) NDA for Parkinson’s Disease Psychosis
Sep  3, 2015Acadia Pharmaceuticals Submits NDA for Nuplazid for the Treatment of Parkinson’s Disease Psychosis
Mar 21, 2013ACADIA Announces Presentation of Data from Its Pivotal Phase III Parkinson's Disease Psychosis Study with Pimavanserin at the American Academy of Neurology Annual Meeting
Nov 27, 2012ACADIA Announces Pimavanserin Meets Primary and Key Secondary Endpoints in Pivotal Phase III Parkinson's Disease Psychosis Trial

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