Astellas introduces Myrbetriq™, a new class of treatment for Canadian patients with overactive bladder

Astellas introduces Myrbetriq™, a new class of treatment for Canadian 
patients with overactive bladder 
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 women(6) suffer from OAB 
symptoms(7), 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 nocturia)
    --  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 β3-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. "β3-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 patients."

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."

About Myrbetriq(11)

Myrbetriq has been studied extensively in more than 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 (52%).

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.

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 website: 
www.astellas.ca.

(1) Thom DH. Overactive bladder. Epidemiology and impact on quality of life. Contemp Ob/Gyn 2000; (Summer Suppl) 6-14.

(2) Stewart WF, et al. Prevalence and Burden of Overactive Bladder in the United States. World J Urol 2003; 20:327-336.

(3) Ouslander, J. Management of Overactive Bladder. The New England Journal of Medicine (Review Article) 2004; 350:786-
99.

(4) Ouslander, J. Management of Overactive Bladder. The New England Journal of Medicine (Review Article) 2004; 350:786-
99.

(5) Brown J, et al. Urge Incontinence: The Patient's Perspective. Journal of Women's Health 1998; 7:1263-1269.

(6) Irwin DE, Milsom I, et al. Population-Based Survey of Urinary Incontinence, Overactive Bladder, and Other Lower 
Urinary Track Symptoms in Five Countries: Results of
the EPIC Study. Euro Urol. 2006; Supplements 6:4-9.

(7) Mayo Clinic. Overactive Bladder Symptoms.
http://www.mayoclinic.com/health/overactive-bladder/DS00827/DSECTION=symptoms.
Accessed on February 21, 2013.

(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.

(12) Abrams P, et al. The Standardisation of Terminology of Lower Urinary Tract Function. Neurourology and  Urodynamics 
2002; 21:167-178.

(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 Bladder and how are they Managed? BJU Int. 2001 
87:760-766.

(16) Farage MA, et al. Psychosocial and Societal Burden of Incontinence in the Aged Population. Arch Gynecol Obstet. 
April 2008; 277(4):285-90.

(17) Stewart K, et al. Overactive Bladder Patients and the Role of the Pharmacist. J Am Pharm Assoc 2002;42:469-78.



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SOURCE: Astellas Pharma Canada, Inc.

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CO: Astellas Pharma Canada, Inc.
ST: Ontario
NI: MTC HEA NP 

-0- Apr/10/2013 12:00 GMT


 
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