Janssen's quarterly schizophrenia drug approved in EU
Janssen’s three-monthly injection for schizophrenia, Trevicta (paliperidone palmitate), has been approved in Europe, providing the longest dosing interval for an antipsychotic medicine in the EU.
The drug is indicated for maintenance treatment of schizophrenia in adults who have been stabilised on Janssen’s Xeplion, a monthly formulation with the same active ingredient, approved in 2011.
Janssen noted that the drug will allow for fewer administrations compared with currently available antipsychotics and may improve outcomes for patients, carers and healthcare professionals.
The quarterly injection regimen will offer eligible patients greater freedom and an opportunity to focus less on taking their medication, and more on getting and staying well, Janssen said.
Clinical trials had found Trevicta to be at least as effective in preventing relapse as Xeplion and was not associated with any unexpected safety signals, the company noted.
Approval was based on two phase 3 studies, one of which compared Trevicta with the monthly formulation.
The most frequently observed adverse drug reactions, reported in 5% or less of patients, were increased weight, upper respiratory tract infection, headache, insomnia and injection site reaction.
Approval follows a recommendation by the European Medicines Agency’s CHMP in April and allows for marketing in all 28 EU member states.
Dr Rozlyn Bekker, medical director, Janssen UK & Ireland, said: “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.”
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