European Commission approves TREVICTA (paliperidone palmitate 3-monthly injection), for schizophrenia
Janssen has announced that the European Commission (EC) has approved the use of TREVICTA® (paliperidone palmitate, a 3-’monthly injection) for the maintenance treatment of schizophrenia. Paliperidone palmitate 3-monthly injection 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, and therefore may improve outcomes for patients, carers and healthcare professionals.1,2 Paliperidone palmitate 3-monthly injection is indicated for the maintenance treatment of schizophrenia in adult patients who have been stabilised on once-monthly paliperidone palmitate, preferably for four months or more.1 XEPLION® (paliperidone palmitate 1-monthly) was approved in 2011 as a once monthly atypical long acting injection to treat schizophrenia in the European Union.3
“This approval is a significant step forward for people living with schizophrenia in Europe.” said Dr Rozlyn Bekker, Medical Director, Janssen UK & Ireland. “With fewer administrations per year compared to other approved treatments, paliperidone palmitate 3-monthly injection can enable people with schizophrenia to focus on other important aspects of their life and less on the burden of medication. The extended duration of treatment possible with paliperidone palmitate 3-monthly injection has the potential to reduce the likelihood of relapse and may provide helpful support to patients and reduce the need for intervention by their healthcare professional.”
The Marketing Authorisation for paliperidone palmitate 3-monthly injection is based on two Phase 3 studies.2,4 The first was a randomised, multi-centre, double-blind, placebo-controlled relapse prevention study in more than 300 patients with schizophrenia.4 The second study was a randomised, multi-centre, double-blind, clinical trial comparing the efficacy and safety of paliperidone palmitate 3-monthly and 1-monthly formulations.2 Paliperidone palmitate 3-’monthly injection 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.1,2,4
The decision from the EC follows a Positive Opinion recommending the approval of paliperidone palmitate 3-monthly injection from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in April 2016. This approval allows for the marketing of paliperidone palmitate 3-monthly injection, in all 28 countries of the European Union.