New Bi Weekly Injectable Treatment for Schizophrenia Approved in Canada RISPERDAL(reg) CONSTA(reg)

Main Category: Schizophrenia
Article Date: 06 Aug 2004 - 11:00 PDT

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Administered every two weeks, RISPERDAL(reg) CONSTA(reg) reduces hospitalization(1) and addresses treatment issue of missed medication

RISPERDAL(reg) CONSTA(reg) (risperidone), the first newer-generation (atypical) antipsychotic medication in a prolonged release suspension, is now approved by Health Canada for the treatment of symptoms of schizophrenia and related psychotic disorders. Administered once every two weeks by intramuscular injection, it provides consistent relief of symptoms2, giving patients an alternative to daily oral medication.

Schizophrenia is a chronic, highly debilitating psychiatric disorder that typically develops in adolescence or the early 20s3.

Approximately one percent of the population - some 300,000 Canadians - have schizophrenia4. People with schizophrenia occupy over 30,000 hospital beds every year in Canada5. According to Statistics Canada, schizophrenia makes up the second highest number of all hospitalizations for identified mental illness6. The direct and indirect costs attributed to schizophrenia in Canada total more than four billion dollars annually7. Moreover, patients suffering from this disorder stay in hospital longer than any other patients except those receiving rehabilitation services8.

In a one-year clinical trial of RISPERDAL(reg) CONSTA(reg), the need for re-hospitalization decreased continuously during the course of the study, from 38 percent prior to study entry to 12 percent during the last twelve weeks of the study9.

As many as 75 percent of patients have difficulty taking their oral medication on a regular basis or stop taking it all together - a major challenge of current schizophrenia treatment10. Regularly missed doses of antipsychotic medication can lead to relapse and a return to symptoms of schizophrenia11. These include delusions and visual and/or auditory hallucinations (seeing and hearing things that don't exist). With each relapse the illness may worsen12.

"In taking care of my patients, prevention of relapse and hospitalization is a major goal in the treatment of schizophrenia," says Dr. Joel Jeffries, a staff psychiatrist at the Centre for Addiction and Mental Health who has specialized in the treatment of the illness for over 30 years. "Relapses can be devastating for a schizophrenia patient and can lead to hospitalization. My experience shows that it's not unusual for relapse recovery to take up to one year - often causing patients to lose social ties and any progress they've made."

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.

"When medication is taken irregularly there is a great risk of relapse into psychosis and with each relapse the illness may worsen13. Long-acting injections maintain medication levels and help avoid this problem14," comments Dr. Jeffries. "This new option for patients acts over a two week period, with a better side-effect profile than existing injectable medications."

About RISPERDAL(reg) CONSTA(reg)

The extended effect of RISPERDAL(reg) CONSTA(reg) is possible using a proprietary technology called Medisorb(reg) developed by U.S.-based Alkermes, Inc. A suspension of risperidone "microspheres" - in which the medication is encapsulated in tiny spheres of biodegradable polymer - is injected into the muscle, where they gradually degrade at a controlled rate. RISPERDAL(reg) CONSTA(reg) is stored in a refrigerated environment.

The effectiveness of RISPERDAL(reg) CONSTA(reg) was established in a 12-week, placebo-controlled study in 400 adults with schizophrenia15 both in inpatient and outpatient settings16. Patients who received RISPERDAL(reg) CONSTA(reg) experienced significantly greater improvements in both positive (psychological disturbances "added" as a result of the disorder, such as hallucinations, delusions, suspiciousness and paranoia) and negative symptoms (normal functioning that the patient has "lost", resulting in lack of initiative and loss of normal enjoyment) than did those who were administered placebo.

The most common side effects experienced by patients taking RISPERDAL(reg) CONSTA(reg) during this 12-week study were headache, agitation, psychosis, insomnia, dizziness, rhinitis and pain17. Overall, similar proportions of patients reported adverse events in the placebo and RISPERDAL(reg) CONSTA(reg) groups (80 percent versus 83 percent), and serious adverse events were more common in the placebo group (23.5 percent) than in the RISPERDAL(reg) CONSTA(reg) groups (13 percent in the 25 mg group and 14 percent in the 50 mg group).

To date, RISPERDAL(reg) CONSTA(reg) has been approved in 58 countries around the world. In Canada, RISPERDAL(reg) CONSTA(reg) will be marketed by Janssen-Ortho Inc.

About 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.

References:

1 Llorca, PM., et al. Re-hospitalization rates with long-acting risperidone injection are lower than those reported for other antipsychotics. Poster presented at the 23rd Congress of the Collegium Internationale Neuropsychopharmacologicum, Montreal, Canada June 2002.

2 Reference - Canadian product monograph.

3 NIH Publication No. 99-3517.

4 Health Canada: A report on mental health in Canada, 2002, document available at www.schizophrenia.ca (accessed November 4, 2003).

5 Statistics Canada, 1999-2000. Available at www.statcan.ca/english/Pgdb/health56a.htm (accessed December 22, 2003).

6 Ibid.

7 Health Canada: A report on mental illness in Canada, 2002. Available at www.hc-sc.gc.ca/pphb-dgspsp/publicat/miic-mmac/ (accessed December 22, 2003).

8 Tsuyuki RT, et al. Contemporary burden of illness of congestive heart failure in Canada. Can J Card. 2003, March: 436-438.

9 Chue P, Devos E, et al. Hospitalization Rates in Patients During Long-term Treatment with Long-Acting Risperidone Injection. Poster presented at: Annual Meeting of the American Psychiatric Association Institute on Psychiatric Services, 2002; Chicago, Illinois.

10 Weiden, PJ, Zygmunt, Am J of Prac Psych Behavior Health. 1997, March: 106-110

11 Health Canada: A report on mental illness in Canada, 2002. Available at www.hc-sc.gc.ca/pphb-dgspsp/publicat/miic-mmac/ (accessed December 22, 2003).

12 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.

13 Ibid.

14 Kane JM., Drug therapy: schizophrenia. N Engl J Med 1996;334(1):34-41.

15 Kane, JM., Long-Acting injectable risperidone: efficacy and safety of the first long-acting atypical antipsychotic, Am J of Psych. 2003, 160:6:1125.

16 Ibid.

17 Ibid.