Trevicta® (paliperidone palmitate 3-monthly injection) Has Been Recommended by the Scottish Medicines Consortium (SMC) for Use in NHS Scotland Without Restriction for the Maintenance Treatment of Schizophrenia

HIGH WYCOMBE, England, September 14, 2016 /PRNewswire/ --

PRESS RELEASE FOR MEDICAL AND TRADE MEDIA ONLY  

Janssen announced today that the Scottish Medicines Consortium (SMC) has accepted paliperidone palmitate (Trevicta^®) for use within NHS Scotland. Paliperidone palmitate (Trevicta^®), a 3-monthly injection is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on one-monthly paliperidone palmitate injectable product. This new formulation of paliperidone palmitate is administered every three months and is available at pro-rata cost to the monthly formulation.

The positive recommendation of Trevicta^® by the SMC is an important step forward for people living with schizophrenia in Scotland, who will now have routine access to an extended duration treatment which has the potential to reduce the likelihood of relapse.

The reduced injection frequency may provide helpful support to patients by reducing injection frequency, which may free up time for other interventions to optimise mental and physical health outcomes.^[1]

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^[2] and it is most likely to start between the ages of 15 to 35 years, affecting about 1 in every 100 people during their lifetime.^[3] It is estimated that a total of 12,000 individuals with schizophrenia were in contact with health services in Scotland in 2004.^[4]

Trevicta ^®paliperidone palmitate 3-monthly injection) provides the longest dosing interval available for an antipsychotic medication, allowing patients to maintain an optimal level of treatment with fewer administrations compared to currently available antipsychotic treatments, which could improve outcomes for patients, carers and healthcare professionals.^[5] Trevicta ^®paliperidone palmitate 3-monthly injection), with its longer dosing interval, has been shown to decrease the likelihood of hospital admissions compared to placebo.^[6]

"This is a significant step forward in the treatment of schizophrenia providing an option that will be welcome news to patients and prescribing healthcare practitioners in Scotland. This decision is the result of ongoing collaboration between Janssen and the SMC to achieve patient access to our medicines," comments Jennifer Lee, Director of Health Economics, Market Access & Reimbursement at Janssen UK. "Trevicta^® (paliperidone palmitate 3-monthly injection) has the potential to contribute towards an improved quality of life for people living with schizophrenia, and has the potential to reduce the likelihood of relapse," she continues.

About Trevicta^® (paliperidone palmitate 3-monthly injection)

Trevicta^® (paliperidone palmitate 3-monthly injection) is an atypical antipsychotic medication, approved by the European Commission in May 2016, for the maintenance treatment of schizophrenia in Europe.^[7]

Trevicta^® (paliperidone palmitate 3-monthly injection) is indicated for maintenance treatment of schizophrenia in adult patients who are clinically stable on XEPLION^® (paliperidone palmitate once-monthly). XEPLION^® was approved in 2011 as a 1-monthly atypical long-acting injection to treat schizophrenia in Europe and has previously been proven to help people with schizophrenia control their symptoms and avoid relapse.^{[8],[9],[10],[11]}

This is the first medication for schizophrenia that is administered four times a year, providing the longest dosing interval currently available for an antipsychotic medication.^[5]

Further information can be found relating to the SMC's decision at the following: https://www.scottishmedicines.org.uk/SMC_Advice/Forthcoming_Submissions/paliperidone_palmitate_3-monthly_Trevicta

For more information including the full SPC please visit: https://www.medicines.org.uk/emc/medicine/32050

About Schizophrenia 

Schizophrenia is a complex and chronic brain disorder, in which symptoms can be severe and disabling and can affect all aspects of a person's daily life. It affects people from all countries, socio-economic groups and cultures. Its prevalence is similar around the world - almost one person in every 100 will develop schizophrenia before they reach the age of 60, with men slightly more at risk.^[12],[13]

There is no single cause of schizophrenia. Different factors acting together are thought to contribute to the development of the illness. Both genetic and environmental factors seem to be important.^[14] The symptoms of schizophrenia can include hallucinations, delusions, lack of emotional response, social withdrawal/depression, apathy and a lack of drive or initiative.^[12]

Schizophrenia is typically a lifelong condition but there are treatments that can be beneficial. Clinical guidelines recommend that the optimal treatment package is a combination of antipsychotic medication along with psychotherapy, psycho-education and self-help.^[15] Effective treatment may allow people with the condition to enjoy a more fulfilling, well rounded life, which may include returning to work or study, independent living and social relationships, which in turn can aid their recovery.^[15]

About Janssen  

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. The legal entity for Janssen in the UK and Ireland is Janssen-Cilag Ltd. Please visit http://www.janssen.co.uk for more information.

References 

1. Savitz AJ et al. Efficacy and Safety of Paliperidone Palmitate 3-Month Formulation for Patients with Schizophrenia: A Randomized, Multicenter, Double-Blind, Noninferiority Study. International Journal of Neuropsychopharmacology 2016. Jul 5;19(7) 

2. Living with Schizophrenia. Facts and Figures. Available at: https://www.livingwithschizophreniauk.org/facts-and-figures/   

3. Royal College of Psychiatrists. Schizophrenia: key facts. Available at: http://www.rcpsych.ac.uk/healthadvice/problemsdisorders/schizophreniakeyfacts.aspx   

4. Overview of mental health services. Audit Scotland. May 2009. Available at: http://www.audit-scotland.gov.uk/docs/health/2009/nr_090514_mental_health.pdf   

5. Savitz AJ et al. Efficacy and Safety of Paliperidone Palmitate 3-Month Formulation for Patients with Schizophrenia: A Randomized, Multicenter, Double-Blind, Noninferiority Study. International Journal of Neuropsychopharmacology 2016. Jul 5;19(7) 

6. Woodruff et al. Health care resource use of paliperidone palmitate 3-month injection versus placebo: an analysis of the PSY-3012 Phase 3 clinical trial hospital data. P6-115 Poster presented at American Psychiatric Association 168th Annual Meeting 16-20 May 2015; Toronto, Canada 

7. European Medicines Agency. EPAR Summary. Trevicta. Available at:  http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/004066/WC500180643.pdf (last accessed September 2016) 

8. Pandina et al. A randomised, placebo controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. Journal of Clinical Psychopharmacology 2010;30:235-244. 

9. 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 

10. 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. Schizophrenia Research 2010;116(2):107-117. 

11. Gopal S, et al. A 52-week open-label study of the safety and tolerability of paliperidone palmitate patients with schizophrenia. Journal of psychopharmacology 2011 May;25(5):685-97. 

12. American Psychiatric Association (APA). Practice guideline for the treatment of patients with schizophrenia. Second edition 2004;42. Available at: http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/schizophrenia.pdf 

13. Picchioni MM et al. Schizophrenia. BMJ 2007;335(7610):91-5. 

14. Lang U et al. Molecular mechanisms of schizophrenia. Cell Physiol Biochem 2007;20:687. 

15. National Institute for Clinical Excellence: Psychosis and schizophrenia in adults: prevention and management; National Clinical Practice Guidelines Number CG178. Available at: https://www.nice.org.uk/guidance/cg178   

PHGB/PSY/0916/0001
September 2016