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news.Johnson & Johnson company Janssen-Cilag International (Janssen) has submitted an extended marketing authorisation application (MAA) to the European Medicines Agency (EMA) for paliperidone palmitate once-every-three-months formulation to treat schizophrenia in adults.
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Paliperidone palmitate once-monthly is an atypical long-acting injection to treat schizophrenia and is now approved in more than 80 countries, while the drug is marketed as Xeplion in the European Union (EU).
If approved, it will be the first long-acting antipsychotic schizophrenia medication to be administered four times a year.
Janssen Neuroscience and Pain European Therapeutic Area leader Andreas Schreiner said: "This treatment has the potential to offer patients a new dosing schedule, which may result in improved care for many people with schizophrenia.
"We look forward to working with the EMA to make this long-acting therapy available for the treatment of patients with schizophrenia in Europe."
The MAA submission of paliperidone palmitate once-every-three-months is based on two Phase III studies.
First of the two studies is a randomised, multi-centre, double-blind, placebo-controlled relapse prevention trial in more than 500 patients with schizophrenia and it was also the basis for the US Food and Drug Administration (FDA) submission.
The second study is a randomised, double-blind non-inferiority clinical trial of paliperidone palmitate once-every-three-months and once-monthly formulations.
Paliperidone palmitate once-every-three-months formulation, which obtained FDA priority review and is currently approved and launched in the US as Invega Trinza for patients previously treated with the once-monthly formulation, contains the same active substance as Xeplion but with an extended dosing interval.
The drug can help people with schizophrenia to maintain continuous treatment, control their symptoms and avoid relapse.
Following approval, the once-every-three-months formulation of paliperidone palmitate will be marketed as Trevicta in Europe.
Image: Janssen’s paliperidone palmitate once-monthly, a long-acting injection to treat schizophrenia, is marketed as Xeplion in the EU. Photo: courtesy of Baitong333/ freedigitalphotos.net