Skip to main content
Log in

Pimavanserin: First Global Approval

  • AdisInsight Report
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

Pimavanserin (Nuplazid™) is a selective and potent serotonin 2A (5-HT2A) receptor inverse agonist and antagonist developed by ACADIA Pharmaceuticals that has been approved in the US as a treatment for patients with hallucinations and delusions associated with Parkinson’s disease psychosis. Up to 60 % of patients with Parkinson’s disease may develop Parkinson’s disease psychosis, which is associated with increased morbidity and mortality and has few treatment options. This article summarizes the milestones in the development of pimavanserin leading to this first approval for the treatment of hallucinations and delusions in patients with Parkinson’s disease psychosis.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Forsaa EB, Larsen JP, Wentzel-Larsen T, et al. A 12-year population-based study of psychosis in Parkinson disease. Arch Neurol. 2010;67(8):996–1001.

    Article  PubMed  Google Scholar 

  2. Acadia Pharmaceuticals. ACADIA Pharmaceuticals and Biovail form collaboration to develop and commercialize pimavanserin in North America [media release]. 4 May 2009. http://www.acadia-pharm.com.

  3. Acadia Pharmaceuticals Inc. ACADIA Pharmaceuticals enters agreement with Biovail to conclude collaboration and regain North American rights to pimavanserin [media release]. 28 Oct 2010. http://www.acadia-pharm.com.

  4. Vanover KE, Weiner DM, Makhay M, et al. Pharmacological and behavioral profile of N-(4-fluorophenylmethyl)-N-(1-methylpiperidin-4-yl)-N′-(4-(2- methylpropyloxy)phenylmethyl) carbamide (2R,3R)-dihydroxybutanedioate (2:1) (ACP-103), a novel 5-hydroxytryptamine2A receptor inverse agonist. J Pharmacol Exp Ther. 2006;317(2):910–8.

    Article  CAS  PubMed  Google Scholar 

  5. Vanover KE, Robbins-Weilert D, Wilbraham DG, et al. Pharmacokinetics, tolerability, and safety of ACP-103 following single or multiple oral dose administration in healthy volunteers. J Clin Pharmacol. 2007;47(6):704–14.

    Article  CAS  PubMed  Google Scholar 

  6. Vanover KE, Robbins-Weilert D, Wilbraham DG, et al. The effects of food on the pharmacokinetics of a formulated ACP-103 tablet in healthy volunteers. J Clin Pharmacol. 2007;47(7):915–9.

    Article  CAS  PubMed  Google Scholar 

  7. Cummings J, Isaacson S, Mills R, et al. Pimavanserin for patients with Parkinson’s disease psychosis: a randomised, placebo-controlled phase 3 trial. [Erratum appears in Lancet. 2014 Jul 5;384(9937):28]. Lancet. 2014;383(9916):533–40.

    Article  CAS  PubMed  Google Scholar 

  8. Mills R, Friedman JH, Ondo W, et al. Efficacy and tolerability of pimavanserin in PD psychosis: analysis of an integrated phase 3 placebo-controlled dataset [abstract no. 156]. Mov Disord. 2015;30(Suppl 1):S60.

    Google Scholar 

  9. Mills R, Isaacson S, Azulay JP, et al. Long-term effectiveness of Nuplazid™ (pimavanserin) in PD psychosis: data from 2 open-label studies [abstract no. P 2.056]. Parkinsonism Relat Disord. 2016;22(Suppl 2):e92–3.

    Google Scholar 

  10. Meltzer HY, Mills R, Revell S, et al. Pimavanserin, a serotonin 2A receptor inverse agonist, for the treatment of Parkinson’s disease psychosis. Neuropsychopharmacology. 2010;35:881–92.

    Article  CAS  PubMed  Google Scholar 

  11. Meltzer HY, Elkis H, Vanover K, et al. Pimavanserin, a selective serotonin (5-HT)2A-inverse agonist, enhances the efficacy and safety of risperidone, 2 mg/day, but does not enhance efficacy of haloperidol, 2 mg/day: comparison with reference dose risperidone, 6 mg/day. Schizophr Res. 2012;141(2–3):144–52.

    Article  PubMed  Google Scholar 

  12. Acadia Pharmaceuticals Inc. Prescribing information for Nuplazid™ (pimavanserin) tablets, for oral use. 2016. http://www.acadia-pharm.com/wp-content/uploads/2016/04/NUPLAZID-pimavanserin-Package-Insert.pdf. Accessed 3 May 2016.

Download references

Disclosure

The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis, Springer SBM.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Anthony Markham.

Additional information

This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Markham, A. Pimavanserin: First Global Approval. Drugs 76, 1053–1057 (2016). https://doi.org/10.1007/s40265-016-0597-9

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-016-0597-9

Keywords

Navigation