Paliperidone Palmitate Intramuscular 3-Monthly Formulation: A Review in Schizophrenia
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A 3-monthly formulation of intramuscular paliperidone palmitate (3-monthly paliperidone palmitate) has recently been approved for the maintenance treatment of schizophrenia in adult patients in the EU (Trevicta®), following earlier approval in the USA (Invega Trinza®). This narrative review discusses the clinical use of 3-monthly paliperidone palmitate in the maintenance treatment of schizophrenia in adult patients and summarizes its pharmacological properties. The efficacy of the 3-monthly paliperidone palmitate formulation as a maintenance treatment for schizophrenia has been demonstrated in well designed, phase III trials. Three-monthly paliperidone palmitate was more effective than placebo in delaying time to relapse and reducing relapse rates, and was noninferior to 1-monthly paliperidone palmitate in the proportion of patients that remained relapse-free. The 3-monthly formulation was also more effective than placebo in controlling the symptoms of schizophrenia, whilst not differing significantly from the 1-monthly formulation in terms of symptomatic control. Three-monthly paliperidone palmitate was generally well tolerated in clinical trials, with a tolerability profile consistent with that of the 1-monthly formulation. In conclusion, 3-monthly paliperidone palmitate is a useful treatment option for adult patients with schizophrenia who are adequately treated with the 1-monthly formulation, particularly for those who would prefer, or may benefit from, longer dosing intervals.
KeywordsSchizophrenia Placebo Recipient Paliperidone Paliperidone Palmitate Noninferiority Trial
During the peer review process, the manufacturer of the paliperidone palmitate 3-monthly formulation was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding.
Conflict of interest
Yvette Lamb and Gillian Keating are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.
- 9.European Medicines Agency. Trevicta (paliperidone palmitate) prolonged release suspension for injection: EU summary of product characteristics. 2016. http://www.ema.europa.eu/. Accessed 14 Sep 2016.
- 10.Janssen Pharmaceuticals Inc. Invega Trinza® (paliperidone palmitate) extended-release injectable suspension, for intramuscular use: US prescribing information. 2016. http://www.janssencns.com/. Accessed 14 Sep 2016.
- 13.Karlsson P, Dencker E, Nyberg S, et al. Pharmacokinetics and dopamine D2 and serotonin 5-HT2A receptor occupancy of paliperidone in healthy subjects [abstract no. P.1.053]. Eur Neuropsychopharmacol. 2005;15(Suppl. 3):S386.Google Scholar
- 16.Samtani MN, Rossenu S, Vermeulen A, et al. Paliperidone palmitate 3-month dosing in special patient populations and derivation of secondary pharmacokinetic parameters based on simulations. Biol Psychiatry. 2016;79(9 Suppl 1):353S.Google Scholar
- 19.Mathews M, Nuamah I, Savitz A, et al. Comparison of 3-monthly versus 1-monthly paliperidone palmitate for time to onset and time to resolution of extrapyramidal symptoms in patients with exacerbated schizophrenia. Biol Psychiatry. 2016;79(9 Suppl 1):352S–3S.Google Scholar
- 21.National Institute for Health and Care Excellence. Psychosis and schizophrenia in adults: prevention and management. 2014. http://www.nice.org.uk. Accessed 23 Aug 2016.
- 22.Hasan A, Falkai P, Wobrock T, et al. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of schizophrenia, part 2: update 2012 on the long-term treatment of schizophrenia and management of antipsychotic-induced side effects. World J Biol Psychiatry. 2013;14(1):2–44.CrossRefPubMedGoogle Scholar
- 23.Alphs L, Turkoz I, Fu DJ. Design of the schizophrenia disease recovery evaluation and modification (DREaM) study. Biol Psychiatry. 2015;77(9 Suppl 1):202S.Google Scholar
- 24.Gopal S, Xu H, McQuarrie K, et al. Caregiver burden in schizophrenia: pooled analysis of the involvement evaluation questionnaire data for paliperidone palmitate 3-month formulation. Biol Psychiatry. 2016;79(9 Suppl 1):213S.Google Scholar