Janssen submits European extension marketing authorisation application for paliperidone palmitate

Janssen-Cilag International NV (Janssen) announced the submission of 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.

Janssen-Cilag International NV (Janssen) announced the submission of 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 III studies. The first, which was the basis for the US Food and Drug Administration (FDA) submission, is a randomised, multicentre, double-blind, placebo-controlled relapse prevention study in more than 500 patients with schizophrenia. (1) The second is a randomised, double-blind non-inferiority clinical trial of paliperidone palmitate once-every-three-months and once monthly formulations. (2) The results will be presented at a scientific congress later this year.

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. (3–8) 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 XEPLION but with an extended dosing interval.

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.

References

1. Berwaerts J et al. Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial. JAMA Psych, 2015.
2. Clinical trials. Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia Available at https://clinicaltrials.gov/ct2/show/NCT01515423 (last accessed August 2015).
3. Kane JM. Treatment adherence and long term outcomes. CNS Spectr 2007;12:10(Suppl 17):21–6.
4. Pandina GJ et al. A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. J Clin Psychopharmacol 2010;30:235–44.
5. Bossie CA et al. Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trial. BMC Psychiatry 2011;11:79.
6. Hough D et al. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophr Res 2010;116:107–17.
7. Schreiner A et al. A randomized, active-controlled rater-blinded 2-year study of paliperidone palmitate versus investigators’ choice of oral antipsychotic monotherapy in patients with schizophrenia (PROSIPAL) [Poster 61]. Presented at The 22nd European Congress of Psychiatry, Munich, Germany, 1–4 March 2014.
8. Gopal S et al. A 52-week open-label study of the safety and tolerability of paliperidone palmitate in patients with schizophrenia. J Psychopharmacol 2011;25:685–97.