pimavanserin (Nuplazid)

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[1][2][3][4][5][6][7][8][9][10][11][12]

Indications

Contraindications

Dosage

Tablets: 17 mg

* mix with soft food[9]

Pharmacokinetics

Adverse effects

Boxed Warning:

Drug interactions

  • dosage reduction may be needed with strong CYP3A4 inhibitors
  • dosage increase may be needed with strong CYP3A4 inducers

Mechanism of action

Clinical trials

  • in a trial stopped early for efficacy, patients with dementia-related psychosis with response to pimavanserin had lower risk of relapse with continuation of pimavanserin than discontinuation[8]

More general terms

References

  1. ↑ 1.0 1.1 1.2 Cummings J et al Pimavanserin for patients with Parkinson's disease psychosis: a randomised, placebo-controlled phase 3 trial. The Lancet, Early Online Publication, 1 November 2013 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24183563 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62106-6/abstract
  2. ↑ 2.0 2.1 2.2 2.3 FDA News Release. April 29, 2016 FDA approves first drug to treat hallucinations and delusions associated with Parkinson's disease. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm498442.htm
    Acadia Pharmaceuticals Label Update for NUPLAZID (pimavanserin). Sept 18, 2023 https://acadia.com/media/news-releases/acadia-pharmaceuticals-announces-label-update-for-nuplazid-pimavanserin/
  3. ↑ Windle ML FDA Drug Approvals and Changes: May edition. Medscape. May 20, 2016 http://reference.medscape.com/features/slideshow/drug-review/2016/may
  4. ↑ 4.0 4.1 NEJM JWatch Editors New Parkinson's Drug Under Scrutiny Over Safety Concerns Physician's First Watch, April 27, 2018 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
    Ellis B, Hicken M FDA re-examines safety of controversial new drug. CNN Health. April 25, 2018 https://www.cnn.com/2018/04/25/health/fda-nuplazid-safety-evaluation-invs/index.html
  5. ↑ 5.0 5.1 Velayudhan L, Ffytche D, Ballard C, Aarsland D. New Therapeutic Strategies for Lewy Body Dementias. Curr Neurol Neurosci Rep. 2017 Sep;17(9):68. Review. PMID: https://www.ncbi.nlm.nih.gov/pubmed/28741230
  6. ↑ 6.0 6.1 Monaco K Add-On Nuplazid Gets a Win in Early Schizophrenia Trial - Phase II study met primary efficacy endpoint. MedPage Today September 11, 2020 https://www.medpagetoday.com/meetingcoverage/psychcongress/88578
    Bugarski-Kirola D et al ADVANCE: Phase 2, randomized, double-blind, placebo-controlled study of adjunctive pimavanserin in patients with negative symptoms of schizophrenia. Psych Congress 2020; Poster #106.
  7. ↑ 7.0 7.1 Monaco K Trial: Drug Induces, Maintains Dementia-Related Psychosis Remission - Results pave way for Nuplazid label expansion. MedPage Today September 14, 2020 https://www.medpagetoday.com/meetingcoverage/psychcongress/88607
    Foff E, et al Pimavanserin significantly reduces risk of relapse of dementia-related psychosis: results from the double-blind phase of the HARMONY study. Psych Congress 2020; Poster #187 Foff E, et al Response to pimavanserin treatment in patients with dementia-related psychosis: results From the 12-week, open-label phase of the HARMONY study. Psych Congress 2020; Poster #197
  8. ↑ 8.0 8.1 Grant K Staying on Pimavanserin Cut Dementia-Related Psychosis Relapse. However, late-stage trial couldn't separate efficacy in dementia subtypes. MedPage Today July 21, 2021 https://www.medpagetoday.com/psychiatry/dementia/93689
    Tariot PN, Cummings JL, Soto-Martin ME et al Trial of pimavanserin in dementia-related psychosis. N Engl J Med 2021; 385:309-319, July 22 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34289275 https://www.nejm.org/doi/full/10.1056/NEJMoa2034634
    Friedman JI Pimavanserin in dementia-related psychosis. N Engl J Med 2021; 385:372-373. July 22 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34289282 https://www.nejm.org/doi/full/10.1056/NEJMe2109010
  9. ↑ 9.0 9.1 Tumolo J Mixing Pimavanserin With Soft Food Earns Favorable Ratings for Swallowability, Taste. Annals of Long-Term Care. July 22, 2021
    Forman M, Kouassi A, Brandt T. Palatability and Swallowability of Pimavanserin When Mixed with Selected Food Vehicles: An Exploratory Open-Label Crossover Study. Geriatrics (Basel). 2021;6(2):61. Published 2021 Jun 15. PMID: https://www.ncbi.nlm.nih.gov/pubmed/34203662 PMCID: PMC8293179 Free PMC article
  10. ↑ 10.0 10.1 10.2 George J Parkinson's Drug Tied to Increased Hospitalizations, Death. Mortality risk persisted in people taking pimavanserin. MedPage Today August 17, 2021 https://www.medpagetoday.com/neurology/parkinsonsdisease/94081
    Hwang YJ, Alexander GC, An H et al Risk of hospitalization and death associated with pimavanserin use in older adults with Parkinson disease. Neurology 2021. August 13 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34389652 https://n.neurology.org/content/early/2021/08/13/WNL.0000000000012601.abstract
    Ali F Pimavanserin: A friend or foe in Parkinson disease psychosis. Neurology 2021. August 13 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34389650 https://n.neurology.org/content/early/2021/08/13/WNL.0000000000012656
  11. ↑ 11.0 11.1 Monaco K FDA Advisers Reject Nuplazid for Alzheimer's Disease Psychosis. Weak trial data not enough to persuade panel to recommend approval. MedPage Today June 17, 2022 https://www.medpagetoday.com/psychiatry/alzheimersdisease/99330
  12. ↑ 12.0 12.1 12.2 12.3 Abler V, Brain C, Ballard C, Berrio A, Coate B, Espay AJ. Motor- and cognition-related safety of pimavanserin in patients with Parkinson's disease psychosis. Front Neurol. 2022. October 5 PMID: https://www.ncbi.nlm.nih.gov/pubmed/36277907 PMCID: PMC9580496 Free PMC article

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