Janssen submits Extension MAA for paliperidone palmitate once-every-three-months formulation

Janssen has submitted an Extension Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for paliperidone palmitate once-every-three-months formulation for the treatment of schizophrenia.

If approved, it will be the first antipsychotic schizophrenia medication to be administered four times a year.

“This treatment has the potential to offer patients a new dosing schedule, which may result in improved care for many people with schizophrenia,” said Dr Andreas Schreiner, European Therapeutic Area Leader, Neuroscience and Pain, Janssen. “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 European filing of paliperidone palmitate once-every-three-months is based on two Phase 3 studies. The first, which was the basis for the US Food and Drug Administration (FDA) submission, is a randomised, multi-centre, double-blind, placebo-controlled relapse prevention study in more than 500 patients with schizophrenia. The second is a randomised, double-blind non-inferiority clinical trial of paliperidone palmitate once-every-three-months and once-monthly formulations. The results will be presented at a scientific congress later this year.

If approved, paliperidone palmitate once-every-three-months will be marketed as Trevicta in Europe

Paliperidone palmitate once-monthly (marketed as Xeplion® in the European Union) is an atypical long-acting injection to treat schizophrenia and is now approved in more than 80 countries. It can help people with schizophrenia to maintain continuous treatment, control their symptoms and avoid relapse. This may allow people with the condition to focus on shaping their future and living their life, which can include returning to work or study, independent living and social relationships. Paliperidone palmitate once-every-three-months formulation, which obtained FDA priority review and is currently approved and launched in the US (and marketed as Invega Trinza®) for patients previously treated with the once-monthly formulation, contains the same active substance as Xexplion but with an extended dosing interval. If approved, it will be marketed as Trevicta® in Europe.

Schizophrenia is a complex illness in which a person has difficulties in their thought processes, leading to hallucinations, delusions, disordered thinking and unusual speech or behaviour (known as ‘psychotic symptoms’). These symptoms mean that people with schizophrenia can find it difficult to interact with others and may withdraw from everyday activities and the outside world. In addition, many people with schizophrenia find it difficult to take their medication continuously, and even short interruptions can lead to a relapse. If approved, this additional once-every-three-months treatment option would offer healthcare professionals the ability to give suitable patients greater independence by enabling them to focus less on taking their medication and more on other aspects of their treatment plan.