INVEGA* controls symptoms around the clock and may reduce the risk of some drug interactions, which can be a problem in the treatment of schizophrenia
TORONTO, ON, October 1, 2007 – Health Canada has approved INVEGA* (paliperidone, molecular structure shown on right) for the treatment of schizophrenia (1). INVEGA is the only once-daily oral treatment for schizophrenia that uses a unique OROS* technology designed to deliver and sustain a controlled level of medication throughout the day (1). Moreover, INVEGA is not extensively metabolized in the liver, which may mean fewer drug interactions for patients (1,3).People with schizophrenia are often on more than one medication (called polypharmacy) for conditions including anxiety disorders, depression, cardiovascular disease, diabetes, HIV and hepatitis C(3). In fact, studies have shown that 43 per cent of patients on an atypical antipsychotic are on five or more other medications (4). Taking several drugs along with antipsychotic medication can alter the potency of the medication and may lead to serious and potentially life-threatening adverse events (3). Thus, reducing the risk of drug interactions in the treatment of schizophrenia is an important consideration.
“People with schizophrenia are an extremely difficult population to treat and finding the right therapy can be a challenge,” said Dr. Roger McIntyre, Associate Professor of Psychiatry and Pharmacology, University of Toronto and psychiatrist at Toronto Western Hospital. “The approval of INVEGA is good news because not only will it consistently control symptoms around the clock, but it’s also an effective option that may help in managing some of the risks associated with polypharmacy - something that is an unfortunate reality when treating people with schizophrenia.”
In placebo-controlled clinical trials, INVEGA was shown to significantly improve the symptoms of schizophrenia and the overall severity of patients’ illness (1). In these trials efficacy was measured using two clinically validated tools commonly used in schizophrenia research: the Positive and Negative Syndrome Scale (PANSS), a tool used to measure the severity of symptoms and the Clinical Global Impression Severity Scale (CGI-S), a tool that measures the overall severity of patients’ illness (1).
Schizophrenia is a chronic and debilitating psychiatric disorder that affects over 325,000 Canadians (5,6). Without consistent and effective medication, relapse is common, and with each relapse the illness may worsen (7,8). People with schizophrenia occupy over 30,000 hospital beds every year in Canada (9). In 2004, the direct and indirect costs of the disease amounted to more than $6 billion, with hospitalization as the biggest contributor to the direct costs at $1.2 billion (10).
“People with schizophrenia require life-long management of their disease,” said Dr. Hani Iskandar, Medical Director, Psychiatric Intensive Care Unit, Douglas Mental Health University Institute, Assistant Professor of Psychiatry, McGill University. “When not properly managed, it can have a profound effect not only on the individual’s wellbeing, but also on the health care system. With more treatment options, clinicians have a better chance of finding a therapy that works and that patients will stay on.”
Preventing relapse is closely related to effective antipsychotic medication and adherence to that treatment. Non-adherence to medication is common in people with schizophrenia and is associated with denial of illness, distressing side effects and complicated dosing schedules (11). In fact, a study of over 1,400 patients with schizophrenia on oral atypical antipsychotic medications showed that 74 per cent of patients discontinued the study medication before 18 months (12). These results demonstrate the high discontinuation rates among this patient population, and the need for multiple treatment options.
About INVEGA
INVEGA is indicated for the treatment of schizophrenia (1). INVEGA is the only oral treatment for schizophrenia that uses a unique OROS technology designed to deliver a controlled flow of medication over a 24-hour period.
The efficacy of INVEGA was demonstrated in clinical studies involving more than 1,300 patients with schizophrenia (1). The studies demonstrated statistically significant improvement. In three short-term six-week trials, all doses of INVEGA demonstrated significant improvements in the mean total score of the PANSS versus placebo (1). Statistically significant improvements were seen in severity of illness of patients as measured by the CGI-S (1). In a longer-term trial, INVEGA was shown to effectively maintain symptom control and significantly delay time to symptom recurrence versus placebo (13).
Most adverse events were comparable to placebo at 3 mg and 6 mg doses, including extrapyramidal side effects and weight gain. Changes in lipid levels, including total cholesterol, LDL, HDL, and triglycerides, were low and comparable with placebo across the dose range. Discontinuation rates due to adverse events were comparable to placebo for all doses of INVEGA (1).
In clinical trials, the most frequently reported side effects for all studied doses included: headache, tachycardia (rapid beating of the heart), akathisia (extreme restlessness), extrapyramidal disorders (e.g., involuntary movements, tremors and rigidity), somnolence, dizziness, sedation, orthostatic hypotension and dry mouth (1 ).
In Canada, INVEGA is marketed by Janssen-Ortho Inc.
Janssen-Ortho Inc.
Janssen-Ortho Inc. is a brand-name pharmaceutical company headquartered in Toronto with a broad range of medications used in psychiatry, neurology, dementia, attention deficit hyperactivity disorder, pain management, women’s health, infectious disease, gastroenterology, and urology.
*All trademark rights used under license.
For more information please contact:
Environics Communications Inc.
Jennifer Casey
(416) 969-2724
jcasey@environicspr.com
Janssen-Ortho Inc.
Suzanne Frost
(416) 449-9444
sfrost@gpcca.jnj.com
References:
1. INVEGA* Product Monograph, Janssen-Ortho Inc., 2007.
2. Davidson M., et al. Efficacy, safety and effect on function of Paliperidone extended-release tablets in schizophrenia: an international 6-week placebo-controlled study. Schizophr. Res.2007, doi:10.1016/j.schres.2007.03.003.
3. Conley R, et al. Drug-Drug Interactions Associated with Second-Generation Antipsychotics: Considerations for Clinicians and Patients. Psychopharmacology Bulletin. 40:1:77-97.
4. Brogan ODB Data, December 2006.
5. NIH Publication No. 06-3517.
6. According to Statistics Canada the Canadian population is 32,852,849 (accessed August 15, 2007 at: www.statcan.ca/menu-en.htm), one per cent of the population is 328,528.
7. Cernansky J, Mahmoud R, Brenner R. A Comparison of risperidone and haloperidol for the prevention of relapse in patients with schizophrenia. N Engl J Med. 2002:346(1):16-22.
8. Health Canada: A Report on Mental Illness in Canada, 2002. (Last accessed July 30, 2007.)
9. Statistics Canada: Hospitalizations for mental disorders, by cause. Available by clicking here. (Last updated accessed March 30, 2004; accessed August 7, 2007).
10. Goeree R, et al. The Economic Burden of Schizophrenia in Canada in 2004, Current Medical Research and Opinion. 2005:21(12):2017-2028.
11. Clinical Practice Guidelines for the Treatment of Schizophrenia. Cnd J Psychiatry. Available at by clicking here. (Last accessed August 14, 2007).
12. Lieberman, J., et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005:353(12):09-23.
13. Kramer M., et al. Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia – a randomized, double-blind, placebo-controlled study. J Clin Psychopharmacology. 2007:27(1):6-14.
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