VRAYLAR® is a new atypical
antipsychotic medication with partial agonist activity at central
dopamine D3 receptors in addition to targeted activity
at D2 and serotonin 5-HT1A and
5-HT2A receptors. 1
MONTREAL, April 27,
2022 /CNW Telbec/ - AbbVie (NYSE: ABBV), a global,
research and development-based biopharmaceutical company announced
today that Health Canada has approved VRAYLAR®
(cariprazine) as monotherapy for the acute management of manic,
mixed, and depressive episodes associated with bipolar l disorder
in adults, as well as the treatment of schizophrenia in
adults.1
Bipolar I disorder is a mental illness characterized by extreme
mood swings that can impact an individuals' ability to think,
behave and function.2 It can consist of three
states which includes manic, depressive, and mixed
episodes.3 While the causes of bipolar I disorder are
unknown, biological factors can play a role and can be difficult to
diagnose due to the wide range of symptoms.3
Schizophrenia is a severe mental illness that can also impact a
person's ability to function, and often presents symptoms that can
change over time. Symptoms can include hallucinations, disorganized
speech, social withdrawal, and catatonic behaviour.3
"I have seen firsthand what impact bipolar l disorder and
schizophrenia can have on a person's life. These are complex
illnesses that can be difficult to treat and manage. It is
important that we have additional treatment options available for
persons affected," says Dr. Roger S.
McIntyre, M.D., FRCPC, Professor of Psychiatry and
Pharmacology, University of
Toronto. "As a healthcare professional, I am pleased
to hear that this treatment is now available for Canadians who live
with bipolar l disorder or schizophrenia."
It's estimated 2.2% of Canadians will experience bipolar l
disorder in their lifetime and can impact both men and women
equally,4 while an estimated 300,000 Canadians are
impacted by schizophrenia.3 Stigma remains prevalent in
both disorders, with patients often experiencing discrimination and
difficulty in accessing resources and treatment.5
"We know that living with bipolar l disorder can present various
challenges impacting the daily lives of patients and their
families," Dave Gallson, National
Executive Director, Mood Disorders Society of Canada. "The Mood Disorders Society of
Canada thanks Health Canada for
the approval of VRAYLAR®, which will support those in
the community in managing this mental illness. It is encouraging to
see new treatment options for people with bipolar I disorder."
"We are pleased to see the progress in new treatments to support
Canadians living with schizophrenia," says Chris Summerville, CEO of the Schizophrenia
Society of Canada. "Patients are
looking for convenient and safe treatments to support their health
and recovery. VRAYLAR® will offer new hope for many
Canadians and help minimize the burdens associated with
schizophrenia to support patients and their caregivers."
"Mental illness affects many Canadians either through personal
experience, or that of a family member, friend, or colleague,"
says Tracey Ramsay, Vice President and General Manager, AbbVie
Canada. "The approval of VRAYLAR® is an
important milestone that will support patients suffering from
bipolar I disorder and schizophrenia. At AbbVie, we are committed
to providing new treatment options to enhance patient care and
support the unmet needs of mental illness community."
About VRAYLAR® (cariprazine)
1
VRAYLAR® is an oral,
once daily atypical antipsychotic approved as monotherapy for the
acute management of manic, mixed, and depressive episodes
associated with bipolar l disorder in adults, as well as the
treatment of schizophrenia in adults.
The mechanism of action of cariprazine in schizophrenia and
bipolar I disorder is unknown. However, the therapeutic effect of
cariprazine may be mediated through a combination of partial
agonist activity at central dopamine D3, D2
and serotonin 5-HT1A receptors and antagonist activity
at 5-HT2A receptors. Cariprazine forms two major
metabolites, desmethyl cariprazine (DCAR) and didesmethyl
cariprazine (DDCAR), that have in vitro receptor binding and
functional activity profiles similar to the parent drug.
VRAYLAR® is contraindicated in patients who are
hypersensitive to cariprazine or to any ingredient in the
formulation, including any non-medicinal ingredient, or component
of the container. VRAYLAR® is also contraindicated
with concomitant use with strong and moderate CYP3A4 inhibitors /
inducers. Due to the slow elimination of cariprazine and its
metabolites, treatment with strong and moderate CYP3A4 inhibitors
must be initiated at least 2 weeks after VRAYLAR
discontinuation.
VRAYLAR is being developed jointly by AbbVie and Gedeon Richter
Plc, with AbbVie responsible for commercialization in the U.S.,
Canada, Japan, Taiwan
and certain Latin American countries (including Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Mexico, Peru
and Venezuela).
Please consult the VRAYLAR® Product Monograph
at www.allergan.ca.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines that solve serious health issues today
and address the medical challenges of tomorrow. We strive to have a
remarkable impact on people's lives across several key therapeutic
areas: immunology, oncology, neuroscience, eye care, virology,
women's health and gastroenterology, in addition to products and
services across its Allergan Aesthetics portfolio. For more
information about AbbVie, please visit us at www.abbvie.ca. Follow
AbbVie Canada on Twitter, on Instagram or find us on LinkedIn.
1 VRAYLAR
Product Monograph. Allergan Inc. April 22nd 2022.
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2 CAMH.
Bipolar Disorder. Retrieved from
https://www.camh.ca/en/health-info/mental-illness-and-addiction-index/bipolar-disorder.
Accessed March 2022.
|
3
Schizophrenia Society of Canada. Learn more about Schizophrenia.
Retrieved from
https://schizophrenia.ca/learn-more-about-schizophrenia/ . Accessed
March 2022.
|
4 Canadian
Psychological Association. "Psychology Works" Fact Sheet: Bipolar
Disorder. Retrieved from
https://cpa.ca/psychology-works-fact-sheet-bipolar-disorder/.
Accessed March 2022.
|
5 CAMH.
Addressing Stigma. Retrieved from
https://www.camh.ca/en/driving-change/addressing-stigma. Accessed
March 2022.
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SOURCE AbbVie Canada