Health Canada approves first treatment for schizophrenia dosed four times a year

93% of patients treated with INVEGA TRINZA^™ remained relapse-free at the end of
long-term relapse prevention trial

TORONTO June 27, 2016 /CNW/ – Janssen Inc. announced today Health Canada has approved INVEGA TRINZA^™ (paliperidone palmitate), an antipsychotic medication for schizophrenia, which provides a new dosing regimen option administered only four times a year — the longest timing available between doses.¹

INVEGA TRINZA^™ , a 3-month injection, is indicated for the treatment of schizophrenia in adult patients.²INVEGA TRINZA^™ is to be used only after INVEGA SUSTENNA^® (1-month paliperidone palmitate prolonged-release injectable suspension) has been established as adequate treatment for at least four months.³ In order to establish a consistent maintenance dose, it is recommended that the last two doses of INVEGA SUSTENNA^® be the same dosage strength before starting INVEGA TRINZA^™.⁴ Health Canadaapproved INVEGA SUSTENNA^® for the treatment of schizophrenia in 2010.⁵

Adherence to medication is often a challenge for Canadians living with schizophrenia,⁶ with not taking medication as prescribed as the most common cause of relapse.⁷ Studies have shown that within the first five years of treatment, up to 80 per cent of people with schizophrenia had experienced one or more relapses. ^{8, 9, 10} Each relapse can result in a reduced response to treatment, putting continued symptom control even further out of reach.¹¹

“Relapse prevention is a critical part of disease management and recovery-focused care for people living with schizophrenia,” says Dr. Philip Tibbo, Director, Nova Scotia Early Psychosis Program in Halifax.^* “The unique dosing of INVEGA TRINZA^™ can offer patients long-term symptom control. This could help to significantly reduce the risk of relapse over time.”

Health Canada’s approval of INVEGA TRINZA^™ is based on two randomized, double-blind trials where patients were first stabilized for 17 weeks on INVEGA SUSTENNA^®. The first, a phase 3 long-term relapse prevention clinical trial, found patients on INVEGA TRINZA^™ demonstrated a significantly longer time to relapse versus placebo.¹² Twenty-three per cent of patients in the placebo group and 7.4 per cent of patients in the INVEGA TRINZA^™ group experienced a relapse event in the study.¹³

The second study was a double-blind, randomized, non-inferiority trial comparing INVEGA TRINZA^™ and INVEGA SUSTENNA^®. The trial found INVEGA TRINZA^™ was non-inferior to INVEGA SUSTENNA^® and safety was comparable between the two medicines.¹⁴

“It’s encouraging to see new progress in Canada for the treatment of schizophrenia,” says Chris Summerville, Chief Executive Officer, Schizophrenia Society of Canada. “With a treatment schedule of only four times a year, patients can focus less on taking the medication every day and more on recovery goals, such as furthering skills and building family and social relationships.”

About Schizophrenia
Schizophrenia is a complex and chronic brain disorder in which symptoms can be severe, disabling and affect all aspects of a person’s daily life. It affects an estimated 350,000 Canadians (or approximately one per cent of the population).^15,16 The cause of schizophrenia is not known, but symptoms of the disease usually begin in early adulthood. While there is no cure for schizophrenia, it can be managed in most patients when they have access to appropriate treatment and follow their prescribed medication regimen, particularly when intervention is sought and received early in the illness.

Clinical Trial Program
Clinical trials showed the overall safety profile of INVEGA TRINZA^™ was similar to that seen with INVEGA SUSTENNA^®. The majority of all adverse events were mild to moderate in severity. The most common adverse events reported in the long-term relapse prevention study (incidence greater than or equal to five per cent and occurring at least twice as often as placebo) were nasopharyngitis (inflammation of the mucous membranes of the nasopharynx), weight increase and headache.¹⁷ The most common adverse events reported in the non-inferiority study by patients receiving INVEGA TRINZA^™ (incidence greater than or equal to five per cent) were weight increase, anxiety and nasopharyngitis.¹⁸

About INVEGA TRINZA^™
Administered by a healthcare professional, INVEGA TRINZA^™, a 3-month injection, is indicated for the treatment of schizophrenia in adult patients.¹⁹ INVEGA TRINZA^™ is to be used only after INVEGA SUSTENNA^® (1-month paliperidone palmitate prolonged-release injectable suspension) has been established as adequate treatment for at least four months.²⁰ In order to establish a consistent maintenance dose, it is recommended that the last two doses of INVEGA SUSTENNA^® be the same dosage strength before starting INVEGA TRINZA^™.²¹ INVEGA TRINZA^™ is approved in the United States and the European Union, and will be available in Canada later this summer.

Please refer to the INVEGA TRINZA^™ Product Monograph for complete prescribing information, including Boxed Warning and Contraindications.

About the Janssen Pharmaceutical Companies
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. Learn more at www.janssen.com/canada. Follow us at @JanssenCanada.

*Dr. Tibbo was not compensated for any media work. He has been a paid consultant to Janssen Inc.

References
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¹ INVEGA TRINZA^™ Product Monograph, Janssen Inc., June 22, 2016.
² INVEGA TRINZA^™ Product Monograph, Janssen Inc., June 22, 2016.
³ INVEGA TRINZA^™ Product Monograph, Janssen Inc., June 22, 2016.
⁴ INVEGA TRINZA^™ Product Monograph, Janssen Inc., June 22, 2016.
⁵ INVEGA SUSTENNA^® Product Monograph, Janssen Inc., December 14, 2015.
⁶ Higashi, Kyoko et al. “Medication Adherence in Schizophrenia: Factors Influencing Adherence and Consequences of Nonadherence, a Systematic Literature Review.” Therapeutic Advances in Psychopharmacology. 3.4 (2013): 200–218. PMC. Web. 21 Aug. 2015.
⁷ Higashi, Kyoko et al. “Medication Adherence in Schizophrenia: Factors Influencing Adherence and Consequences of Nonadherence, a Systematic Literature Review.” Therapeutic Advances in Psychopharmacology. 3.4 (2013): 200–218. PMC. Web. 21 Aug. 2015.
⁸ Robinson DG, Woerner MG, Alvir JM, et al. Predictors of treatment response from a first episode of schizophrenia or schizoaffective disorder. Am J Psychiatry. 1999;156(4):544-9.
⁹ Emsley R, Chiliza B, Asmal L, Harvey BH. The nature of relapse in schizophrenia. BMC Psychiatry. 2013;13:50.
¹⁰ Wiersma D, Nienhuis FJ, Slooff CJ, Giel R. Natural course of schizophrenic disorders: a 15-year followup of a Dutch incidence cohort. Schizophr Bull. 1998;24(1):75-85.
¹¹ Bouhel S et al. Prodromal symptoms in schizophrenic relapse: A descriptive and comparative study. Encephale. 2012:32(5):397-403.
¹² Berwaerts J, Liu Y, Gopal S, 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 Psychiatry. 2015;72(8):830-9.
¹³ Berwaerts J, Liu Y, Gopal S, 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 Psychiatry. 2015;72(8):830-9.
¹⁴ Savitz AJ, Xu H, Gopal S, et al. Efficacy and safety of paliperidone palmitate 3-month formulation for patients with schizophrenia: A randomized, multicenter, double-blind, noninferiority study. Int J Neuropsychopharmacol. 2016.
¹⁵ Schizophrenia Society of Canada. Frequently Asked Questions. Available at: http://www.schizophrenia.ca/faq. Accessed March 8, 2016.
¹⁶ Statistics Canada. Canada’s population estimates, first quarter 2015. Available at: http://www.statcan.gc.ca/daily-quotidien/150617/dq150617c-eng.htm. Accessed March 8, 2016.
¹⁷ INVEGA TRINZA^™ Product Monograph, Janssen Inc., June 22, 2016.
¹⁸ INVEGA TRINZA^™ Product Monograph, Janssen Inc., June 22, 2016.
¹⁹ INVEGA TRINZA^™ Product Monograph, Janssen Inc., June 22, 2016.
²⁰ INVEGA TRINZA^™ Product Monograph, Janssen Inc., June 22, 2016.
²¹ INVEGA TRINZA^™ Product Monograph, Janssen Inc., June 22, 2016.

SOURCE Janssen Inc.

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