Health canada approves Abilify® as first atypical antipsychotic in the treatment of adolescents with schizophrenia
One-third of people living with schizophrenia experience a psychotic episode by age 19
Health Canada has approved Abilify® (aripiprazole) for the treatment of schizophrenia in adolescents age 15 to 17, making it the first atypical antipsychotic to be specifically approved for this use in this patient population.
Schizophrenia is a serious, complex and life-altering mental illness where people experience psychosis or trouble sorting out what is real and not real. They may hear voices that aren't there or become paranoid. About one third of those living with the disease experience their first psychotic episode by age 191. Treatment is an important aspect of managing this disease and can help a young adult with schizophrenia recover to become functional and live a personally and socially satisfying life.
"Adolescence is a critical time in a person’s emotional, social and academic development,” explains Dr. Thomas Hastings, Lead Psychiatrist for the Halton Region Early Intervention in Psychosis Program. “When schizophrenia develops in adolescence the impact on these areas can be profound. We know that early, accurate, diagnosis and comprehensive and effective treatment gives people with schizophrenia the best chance for successful management of this condition. As such, today's news is very important for teens with schizophrenia, as well as their families."
In adolescents, schizophrenia can be hard to recognize and diagnose, especially in its early stages when symptoms are less pronounced. A complicating factor is that substance abuse is often present when psychotic symptoms appear and needs to be ruled out as the cause of these symptoms.
A greater proportion of males with schizophrenia are first affected in adolescence, with 39 per cent of males and 23 per cent of females having their first psychotic episode by age 192. Treatment of schizophrenia remains difficult -over 40 per cent of sufferers stop taking their medication within the first year3.
“Growing up was very difficult for me,” explained Louise, a 29-year-old Canadian who currently uses Abilify, and whose name has been changed to respect her privacy. “I was diagnosed with adolescent schizophrenia 14 years ago and my prognosis was bleak. I was told I would never work, finish school or have a normal life.”
Louise was hospitalized 13 times for her condition, her shortest hospital visit lasting three weeks and the longest six months. She was put on an anti-psychotic drug resulting in her being “stable enough to be home, but not a productive member of society.”
In 2008, she started treatment with Abilify through a special access program and began feeling better after only a few weeks. “Since my diagnosis, I had heard voices every minute, and then within two months the voices were gone. I’ve also lost 80 pounds since starting Abilify, and I don’t sleep 15 hours a day anymore.”
Louise’s condition over the past three years has improved to the point that she is now working in a shop, selling and working with customers. “I love it,” she said. “I’ve even gone back to school.” She did not want to be identified because many people who know her now don’t know about her disease and her past.
Louise is happy to have normal life and wishes the same for others living with schizophrenia. “What I want is for teenagers with schizophrenia to feel like there is hope and that they are not doomed to live ill.”
“We are very pleased that Abilify has received Health Canada approval for adolescent use,” said Chris Summerville, CEO of the Schizophrenia Society of Canada. “It is important recognition of the impact of schizophrenia on young people and we hope it will lead to greater awareness, earlier diagnosis and earlier use of effective treatment.”
About Abilify in adolescents
Abilify is the first and only medication in Canada approved to treat schizophrenia in adolescents 15 to 17 years of age. The approval is based on the results of a 6-week, double-blind randomized, placebo-controlled trial published by Findling et al (Study 31-03-239)4. This trial showed statistically significant differences with Abilify 10-mg and 30-mg compared to placebo with improvements in the mean change from baseline to endpoint on the primary efficacy measure, the Positive and Negative Syndrome Scale (PANSS) total score, and on other measures. Abilify treatment was generally safe and well tolerated5. It offers effective control of the symptoms of schizophrenia associated with social functioning and has been shown to have a good safety and tolerability profile. Abilify improves symptoms such as hallucinations and delusions, and positively impacts functional ability, such as a lack of motivation or social withdrawal.
Abilify (aripiprazole) was the first third-generation antipsychotic medication approved in Canada. It is available by prescription only. It has been approved by Health Canada for the treatment of schizophrenia and related psychotic disorders in adults and for the treatment of schizophrenia in adolescents 15 to 17 years of age. It is also indicated for the treatment of manic or mixed episodes in bipolar I disorder in adults as acute monotherapy or co-therapy with lithium or divalproex sodium when there is an insufficient acute response to these agents alone. Abilifyas co-therapy with lithium or divalproex sodium has been shown to be more effective than placebo plus mood stabilizer in maintaining clinical improvement for up to one year in adult patients with manic or mixed episodes associated with bipolar I disorder.
About Bristol-Myers Squibb Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. Bristol-Myers Squibb Canada is a leading provider of medicines to fight cancer, cardiovascular and metabolic disorders, infectious diseases (including HIV/AIDS), nervous system diseases and serious mental illness. Bristol-Myers Squibb Company is listed on the New York Stock Exchange under the BMY symbol (NYSE:BMY). Bristol-Myers Squibb Canada's operations are headquartered in Montréal, Québec.
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1 American Academy of Child and Adolescent Psychiatry. Practice parameter for the assessment and treatment of children and adolescents with schizophrenia. J Am Acad Child Adolesc Psychiatry. 2001:40(suppl 7):4S-23S.
2 American Academy of Child and Adolescent Psychiatry, Practice parameter for the assessment and treatment of children and adolescents with schizophrenia. J Am Acad Child Adolesc Psychiatry. 2001:40(suppl 7):4S-23S.
3 Zygmunt, A. Interventions to improve medications adherence in schizophrenia. Am J Psychiatry 159:10, October 2002.
4 Findling RL, Rob A, Nyilas M, et al. A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia. Am J Psychiatry. Sept. 2, 2008. doi: 10.1176/appi.ajp.2008.07061035.
5 Findling RL, Rob A, Nyilas M, et al. A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia. Am J Psychiatry. Sept. 2, 2008. doi: 10.1176/appi.ajp.2008.07061035.Back to Public Notices