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NUPLAZID® (pimavanserin) is the first and only medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). We invite you to visit our product website for NUPLAZID for more information and full prescribing information. The product information is for U.S. residents only.
In 2018, the FDA conducted a thorough evaluation of NUPLAZID, which concluded with a public statement on September 20, 2018 that reaffirmed the positive benefit/risk profile of NUPLAZID for patients with hallucinations and delusions associated with PDP.
We refer all healthcare providers, patients, and families to review the full statement issued by the FDA on September 20, 2018, available at https://www.fda.gov/Drugs/DrugSafety/ucm621160.htm.
In line with the FDA evaluation, there is no new safety update to NUPLAZID prescribing information. Key documents prepared during the Tracked Safety Issue (TSI) evaluation of NUPLAZID, which formed the basis of the FDA’s September 20, 2018 public statement, are available below.
In the TSI Integrated Review Memorandum, which incorporated and was informed by the Office of Surveillance and Epidemiology (OSE) Integrated Review and was the basis of the FDA’s September 20, 2018 public statement, the FDA’s Division of Psychiatry Products concluded:
“After a review of post-marketing adverse event reports, prescription data, clinical trial data and the medical literature we have no new or unexpected safety findings for pimavanserin [NUPLAZID]. Post-marketing experience has been consistent with clinical trial experience as reflected in current labeling. The large number of reports of deaths and other serious adverse events relative to the size of the patient population can be explained by 1) the high rates of morbidity and mortality in a population of patients with end-stage Parkinson’s Disease and 2) high reporting rates for serious adverse events, particularly deaths, which appears to be the result of the practices of the specialized distribution system. At this point there is no basis for further action.”
For any questions, comments, or concerns, please contact our Medical Affairs team:
Please see below additional Important Safety Information including Boxed WARNING.
Important Safety Information and Indication for NUPLAZID (pimavanserin)
Indication: NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
Dosage and Administration: Recommended dose: 34 mg capsule taken orally once daily, without titration.
NUPLAZID is available as 34 mg capsules and 10 mg tablets.
Please see full Prescribing Information including Boxed WARNING for NUPLAZID.