The only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis.
About the Treatment
NUPLAZID® (pimavanserin) is the first and only prescription 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).
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.
See below Important Safety Information, including Boxed WARNING.
Tracked Safety Issue Evaluation (TSI)
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.”
Important Safety Information
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
- NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.
- Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
- Warnings and Precautions: QT Interval Prolongation
- NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics.
- NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
- Adverse Reactions: The common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
- Drug Interactions:
- Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
- Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.
Please read the full Prescribing Information, including Boxed WARNING