Janssen says its Trevicta gets European regulatory approval as maintenance therapy for Schizophrenia
pharmafile | June 2, 2016 | News story | Medical Communications, Research and Development | European Commission, Janssen, Trevicta, schizophrenia
Janssen said the European Commission has approved its Trevicta (paliperidone palmitate, a 3‑monthly injection) as maintenance treatment of schizophrenia.
Trevicta is indicated as maintenance treatment of schizophrenia in adult patients who have been stabilised on once-monthly paliperidone palmitate, preferably for four months or more. Xeplion (paliperidone palmitate 1-monthly) was approved in 2011 as a once monthly atypical long acting injection to treat schizophrenia in the European Union.
Rozlyn Bekker, medical director, Janssen UK & Ireland, said: “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 Trevicta is based on two Phase III studies.
The most frequently observed adverse drug reactions include increased weight, upper respiratory tract infection, anxiety, headache, insomnia and injection site reaction, the company said in a statement.
Schizophrenia is a serious mental illness that affects the way a person thinks, feels and behaves. It affects people from all countries, socio-economic groups and cultures. Its prevalence is similar around the world – almost one person in every 100 in the UK will develop schizophrenia, with men slightly more at risk.
Anjali Shukla
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