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Published on 31 May 2016

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European Commission approves TREVICTA® for maintenance treatment of schizophrenia

Janssen-Cilag International NV announced that the European Commission (EC) has approved the use of TREVICTA® (paliperidone palmitate a 3-monthly injection) for the maintenance treatment of schizophrenia in adult patients.

 

Janssen-Cilag International NV announced that the European Commission (EC) has approved the use of TREVICTA® (paliperidone palmitate a 3-monthly injection) for the maintenance treatment of schizophrenia in adult patients.

 

TREVICTA will provide the longest dosing interval available for an antipsychotic medication in the European Union, allowing patients to maintain an optimal level of treatment in their blood with fewer administrations, compared to currently available antipsychotic treatments. This may improve outcomes for patients, carers and healthcare professionals.1,2 TREVICTA is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on XEPLION®, a 1-monthly paliperidone palmitate product that was approved in 2011 for the maintenance treatment of schizophrenia in the European Union.1

This approval is a big step forward for people living with schizophrenia,” said Dr Andreas Schreiner, European Therapeutic Area Leader, Neuroscience and Pain, Janssen. “With fewer administrations per year compared to other approved treatments, TREVICTA can give people with schizophrenia greater freedom to focus on other important aspects of their life and less on their treatment. This new option has the potential to reduce the likelihood of relapse and progression of the disease. It also helps healthcare professionals ensure the person with schizophrenia can benefit from continuous delivery of medication between administrations.

The marketing authorisation for TREVICTA is based on two Phase III studies.2,3 The first was a randomised, multi-centre, double-blind, placebo-controlled relapse prevention study in more than 500 patients with schizophrenia.3 The second was a randomised, multicentre, double-blind study comparing the efficacy and safety of paliperidone palmitate 3-monthly and 1-monthly formulations.2 TREVICTA was found to be at least as effective in preventing relapse as the paliperidone palmitate 1-monthly formulation and was not associated with any new or unexpected safety signals.2

As with all medications, some patients may experience side effects. The most frequently observed adverse drug reactions reported in ≥5% of patients in the two double-blind controlled clinical trials of paliperidone palmitate 3-monthly injection were: increased weight, upper respiratory tract infection, anxiety, headache, insomnia and injection site reaction.1,2,3

The decision from the EC follows a Positive Opinion recommending the approval of TREVICTA from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in April 2016.1 This approval allows for the marketing of TREVICTA in all 28 member states of the European Union as well as the European Economic Area countries (Norway, Iceland and Liechtenstein).

 

References

  1. European Medicines Agency, Committee Medicinal Products for Human Use. Summary of opinion: TREVICTA (paliperidone). 1 April 2016. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/004066/WC500204137.pdf (last accessed May 2016).
  2. Savitz A et al. Efficacy and safety of paliperidone palmitate 3-month formulation for patients with schizophrenia: A randomized, multicenter, double-blind, non-inferiority study. Int J Neuropsychopharmacol 2016 (Feb 22). doi: 10.1093 [Epub ahead of print].
  3. Berwaerts J et al. Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial. JAMA Psych 2015;72(8):830–9.


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