Myrbetriq is now available in pharmacies across Canada
MARKHAM, ON, April 10, 2013 /CNW/ - Overactive bladder (OAB) is a
chronic, debilitating condition that can have a profound, negative
impact on a patient's quality of life. 1 Many patients with OAB are plagued by depression,2 experience a disruption in sleep,3 limit their social activity,4 and experience a loss of control and decreased self-esteem.5
An estimated 2.9 million Canadian men and women6 suffer from OAB symptoms7, which include:
A strong, sudden urge to urinate
The need to urinate more often than usual, usually more than eight times
in a 24 hour period
Waking up two or more times in the night to urinate (a condition called
Urge incontinence, the involuntary loss of urine immediately following
an urgent need to urinate.
Astellas Pharma Canada, Inc., the Canadian subsidiary of Tokyo-based
Astellas Pharma Inc., today announced the availability of Myrbetriq
(mirabegron, extended-release tablets) for the treatment of OAB with
symptoms of urge urinary incontinence, urgency and urinary frequency.8 Myrbetriq is now available in pharmacies across Canada.
"Simply focusing on the treatment of OAB symptoms is not enough for
patients," says Dr. Blair Egerdie, BSc, MD, FRCSC, Investigator,
Mirabegron Phase III trial and Vice President, Medical, St. Mary's
General Hospital, Adjunct Professor of Urology at the University of
Western Ontario. "We know OAB symptoms can be distressing; therefore, a
focus on helping improve quality of life is critical. Everything from
our patient's emotional well-being, to their productivity at work,
mood, and social functioning can be affected. Treatment options that
can help minimize this very real, very personal impact represent an
important achievement in the treatment of OAB."
Myrbetriq's distinct mechanism of action helps to increase bladder
capacity by relaxing the detrusor smooth muscle during the storage
phase of the urinary bladder fill-void cycle.9 This 3-adrenoceptor agonist both reduces the activity of an
overactive bladder as well as treats the related symptoms.1
"Until now, when we've turned to medication to help with OAB symptoms,
we've tried to block the chemical that causes bladder contractions,"
explains Dr. Egerdie. "3-agonists, however, essentially quiet an
overactive bladder by relaxing the bladder, thereby increasing its
capacity. Because OAB affects individuals so differently, these kinds
of treatment options are extremely important to both physicians and
Myrbetriq was evaluated in three, 12-week, double-blind, randomized,
placebo-controlled, parallel group, multicenter clinical trials in
patients with OAB with symptoms of urge urinary incontinence, urgency,
and urinary frequency.
"Now that Myrbetriq is available through pharmacies, Canadian patients
have access to the first new class of medication for the treatment of
OAB in over 30 years," said Michael Tremblay, President, Astellas
Pharma Canada, Inc. "Astellas is committed to improving quality of life
for patients living with overactive bladder, and we are pleased to add
Myrbetriq to our portfolio of treatment options."
Myrbetriq has been studied extensively in morethan 10,000 individuals over 10 years.
The efficacy of Myrbetriq has been evaluated in three phase 3
randomized, double blind, placebo controlled, 12-week studies for the
treatment of OAB with symptoms of urgency and frequency with or without
incontinence. Entry criteria required that patients had symptoms of
overactive bladder for at least three months duration, at least 8
micturitions per day, and at least three episodes of urgency with or
without incontinence over a three day period. The majority of patients
were Caucasian (94%) and female (72%) with a mean age of 59 years
(range 18 - 95 years). The population included both naïve patients who
had not received prior antimuscarinic pharmacotherapy for OAB (48%) and
those who had received prior antimuscarinic pharmacotherapy for OAB
The co-primary efficacy endpoints in all three trials were (1) change
from baseline to end of treatment (Week 12) in mean number of
incontinence episodes per 24 hours and (2) change from baseline to end
of treatment (Week 12) in mean number of micturitions per 24 hours,
based on a three-day micturition diary.
The recommended starting dose for Myrbetriq is 25 mg once daily with or
without food. Based on individual efficacy and tolerability, the dose
may be increased to 50 mg once daily.
About Overactive Bladder
Overactive bladder (OAB) is a symptomatic condition marked by the
sudden, compelling desire to pass urine that is difficult to defer.12 This sudden urge to urinate, which is difficult to suppress, can lead to
the involuntary loss of urine (incontinence).13 OAB occurs when the bladder's smooth muscle, known as the detrusor
muscle, involuntarily contracts, which creates the urgent need to
urinate.14 Rushing to make it to the bathroom in time is common for people with
OAB symptoms occur in approximately equal numbers of men and women, and
are more widespread in older patients of both genders.15 Urge incontinence is the most common form of urinary incontinence in
older adults, but it is not an inevitable consequence of aging and
therefore can, and should, be medically treated.16
OAB can greatly impact patients' lives. Patients who have incontinence
as a result of their OAB symptoms experience an even greater impact on
their quality of life than those who do not experience incontinence.17
About Astellas Pharma Canada, Inc.
Astellas Pharma Canada, Inc., headquartered in Markham, ON, is a
Canadian affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a
pharmaceutical company dedicated to improving the health of people
around the world through the provision of innovative and reliable
pharmaceutical products. The organization is committed to becoming a
global category leader in focused areas by combining outstanding R&D
and marketing capabilities. In Canada, Astellas has an intense
commercial focus on five therapeutic areas - Urology, Immunology,
Infectious Disease, Dermatology and Oncology. For more information
about Astellas Pharma Canada, Inc., please visit the corporate
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|8 Myrbetriq Canadian approved Product Monograph, dated March 4, 2013.
|9 Myrbetriq Canadian approved Product Monograph, dated March 4, 2013.
|10 Myrbetriq Canadian approved Product Monograph, dated March 4, 2013.
|11 Myrbetriq Canadian approved Product Monograph, dated March 4, 2013.
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|13 Mayo Clinic. Overactive Bladder Definition. http://www.mayoclinic.com/health/overactive-bladder/DS00827. Accessed February 23, 2013.
|14 Ouslander, J. Management of Overactive Bladder. The New England Journal of Medicine (Review Article) 2004; 350:786-99.
|15 Milsom I, et al. How Widespread are the Symptoms of an Overactive
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|16 Farage MA, et al. Psychosocial and Societal Burden of Incontinence in
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|17 Stewart K, et al. Overactive Bladder Patients and the Role of the
Pharmacist. J Am Pharm Assoc 2002;42:469-78.|
SOURCE Astellas Pharma Canada, Inc.