Nuplazid
(pimavanserin)
Once Daily 34mg Capsules
About the treatment
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.
Treatment Quick Facts
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Indication
NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson?s disease psychosis.
Recommended Dose
taken orally once daily
NUPLAZID is available as 34 mg capsules and 10 mg tablets.
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Contact UsClinical Trial Details
Methodology
To test the efficacy of NUPLAZID, an FDA-accepted tool measured the changes in the frequency and/or severity of hallucinations and delusions associated with PD psychosis. Each person was assigned to 1 of 2 groups: those who received NUPLAZID 34 mg or those who received placebo. Results were reported at the end of 6 weeks
Duration
Double-blind, randomized, placebo-controlled study
Sample details
Adults (average age 72) diagnosed with hallucinations and delusions associated with PD psychosis
Results
Reduced the frequency and/or severity of hallucinations and delusions
In the clinical trial, the majority of patients who took NUPLAZID experienced fewer and/or less severe hallucinations and delusions associated with PD psychosis. Some patients did not experience any hallucinations or delusions after 6 weeks. Not everyone will respond to NUPLAZID
NUPLAZID had no effect on motor symptoms
Taking NUPLAZID did not affect motor symptoms during the clinical trial compared to a placebo
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.?
Featured Perspectives
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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.
ContraindicationNUPLAZID 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.
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 ReactionsThe most 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 InteractionsCoadministration 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.