See real responses in patients with hallucinations and delusions associated with Parkinson’s disease psychosis1

Proven outcomes as measured by a pivotal Phase 3 trial1,2

The effectiveness of once‑daily NUPLAZID® (pimavanserin) 34 mg for the treatment of Parkinson’s disease psychosis (PDP) was established in a randomized, double-blind, placebo-controlled study1

Based on the unmet need, the FDA granted Breakthrough Therapy designation and accepted NUPLAZID for filing with Priority Review3

The SAPS-PD was adapted from SAPS to specifically assess and detect changes in symptoms of psychosis in patients with Parkinson’s disease (PD)4

Eligibility Criteria and
SAPS-PD Scale

Key eligibility criteria1,2

Inclusion criteria

  • Age ≥40 years
  • PD diagnosis ≥1 year
  • Psychotic symptoms:
    • Occurred following PD onset
    • ≥1 month duration
    • Occurred at least weekly in month before screening
    • Frequent and severe enough to warrant treatment
  • PD meds stable from 30 days prior to entry into study
  • NPI-H+D ≥6 or a score ≥4 on either the H or D domain

Exclusion criteria

  • Psychosis secondary to toxic or metabolic disorder
  • Previous ablative stereotaxic surgery to treat PD
  • Presence of dementia concurrent or before PD
  • Uncontrolled serious medical illness
  • Antipsychotic drugs, centrally acting anticholinergics, or drugs that cause QT prolongation were prohibited
  • MMSE <21 points at screening
  • Presence of delirium


SAPS-PD

The Scale for Assessment of Positive Symptoms–Parkinson’s disease (SAPS-PD) is an FDA-accepted tool for detecting changes in symptoms of psychosis in patients with Parkinson’s disease.1

Severity and frequency of each item are scored on a scale of 0 to 5. Total score may range from 0 to 45, with higher scores reflecting greater severity.4

9 items of SAPS-PD1-4

Hallucinations

  • Auditory hallucinations
  • Voices conversing
  • Somatic or tactile hallucinations
  • Visual hallucinations
  • Global rating of severity of hallucinations

Delusions

  • Persecutory delusions
  • Delusions of jealousy
  • Delusions of reference
  • Global rating of severity of delusions

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Effective in diminishing hallucinations and delusions1

NUPLAZID was more than twice as effective as placebo in reducing hallucinations and delusions associated with PD psychosis1,2

NUPLAZID effectively alleviated symptoms of psychosis with a -5.79 point change from baseline vs -2.73 with placebo—a difference of 37% with NUPLAZID vs 14% with placebo1,2

Symptom improvement with NUPLAZID continued through the 6-week trial period

NUPLAZID is proven to diminish hallucinations and delusions in patients with PD1

Results from a Phase 3, randomized, multicenter, double-blind, placebo-controlled, parallel-group study of PDP patients (N=199). Primary endpoint was change from baseline in the 9-item Scale for the Assessment of Positive Symptoms—Parkinson’s disease (SAPS-PD). Baseline mean values were 15.9 for NUPLAZID, and 14.7 for placebo. Doses of PD medications taken prior to baseline were required to be stable 30 days prior to study start and throughout the study period.1

While the primary endpoint was designed to measure change from baseline to Week 6, a statistically significant difference between NUPLAZID and placebo was observed at Week 4 (P=0.0369) and again at Week 6 (P=0.0014).2

LSM=least-squares mean; SE=standard error.

NUPLAZID is proven to diminish delusions in patients with PD1

At Week 6, NUPLAZID decreased delusions with a -1.95 point change from baseline vs -1.01 for placebo—a difference of 41% with NUPLAZID vs 21% with placebo1,3*

Improvement on 4-item SAPS-PD Delusions symptom domain was shown for NUPLAZID

*Exploratory analysis. Change measured from mean baseline score of 4.78 for NUPLAZID and 4.76 for placebo.

NUPLAZID improves symptoms of PD psychosis1

NUPLAZID is proven to diminish hallucinations in patients with PD1

At Week 6, NUPLAZID reduced hallucinations with a -3.81 point change from baseline vs -1.80 for placebo—a difference of 34% with NUPLAZID vs 18% with placebo1,3*

Improvement on 5-item SAPS-PD Hallucinations symptom domain was shown for NUPLAZID

*Exploratory analysis. Change measured from mean baseline score of 11.13 for NUPLAZID and 9.96 for placebo.

NUPLAZID improves symptoms of PD psychosis1

See real responses in patients with hallucinations and delusions1

Approximately 2 out of 3 patients had a ≥ 3-point improvement with NUPLAZID1

  • A 3-point improvement can mean the difference between daily and occasional symptoms of psychosis3

*Complete response=SAPS-PD score reduced to zero from baseline value. Patients with missing values were counted as nonresponders.

Nearly 14% of patients experienced a complete response with NUPLAZID.1*

Important Safety Information for NUPLAZID (pimavanserin) 17-mg Tablets

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 hypersensitivity reaction to pimavanserin or any of its components. Reactions have included rash, urticaria, tongue swelling, circumoral edema, and throat tightness.

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 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 Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole) increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half. Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reduced efficacy. Increase in NUPLAZID dosage may be needed.

Renal Impairment: No dosage adjustment for NUPLAZID is needed in patients with mild to moderate renal impairment. Use of NUPLAZID is not recommended in patients with severe renal impairment.

Hepatic Impairment: Use of NUPLAZID is not recommended in patients with hepatic impairment. NUPLAZID has not been evaluated in this patient population.

Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated and should therefore be used in pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Pediatric Use: Safety and efficacy have not been established in pediatric patients.

Dosage and Administration

Recommended dose: 34 mg per day, taken orally as two 17-mg tablets once daily, without titration.

Indication

NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

To report SUSPECTED ADVERSE REACTIONS, contact ACADIA Pharmaceuticals Inc. at 1-844-4ACADIA (1-844-422-2342) or FDA at www.fda.gov/medwatch , or call 1-800-FDA-1088.

Please read the full Prescribing Information including Boxed WARNING.

This website is intended for use by US residents.

Important Safety Information for NUPLAZID (pimavanserin) 17-mg Tablets

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 hypersensitivity reaction to pimavanserin or any of its components. Reactions have included rash, urticaria, tongue swelling, circumoral edema, and throat tightness.

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 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 Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole) increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half. Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reduced efficacy. Increase in NUPLAZID dosage may be needed.

Renal Impairment: No dosage adjustment for NUPLAZID is needed in patients with mild to moderate renal impairment. Use of NUPLAZID is not recommended in patients with severe renal impairment.

Hepatic Impairment: Use of NUPLAZID is not recommended in patients with hepatic impairment. NUPLAZID has not been evaluated in this patient population.

Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated and should therefore be used in pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Pediatric Use: Safety and efficacy have not been established in pediatric patients.

Dosage and Administration

Recommended dose: 34 mg per day, taken orally as two 17-mg tablets once daily, without titration.

Indication

NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

To report SUSPECTED ADVERSE REACTIONS, contact ACADIA Pharmaceuticals Inc. at 1-844-4ACADIA (1-844-422-2342) or FDA at www.fda.gov/medwatch , or call 1-800-FDA-1088.

Please read the full Prescribing Information including Boxed WARNING.

This website is intended for use by US residents.

References:

  1. NUPLAZID® (pimavanserin) prescribing information, ACADIA.
  2. Cummings J, Isaacson S, Mills R, et al. Pimavanserin for patients with Parkinson’s disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet. 2014;383(9916):533-540.
  3. Data on file, ACADIA.
  4. Voss T, Bahr D, Cummings J, Mills R, Ravina B, Williams H. Performance of a shortened scale for assessment of positive symptoms for Parkinson’s disease psychosis. Parkinsonism Relat Disord. 2013;19(3):295-299.