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MYRBETRIQ™ (Mirabegron), Overactive Bladder Treatment From Astellas Pharma US, Now Available Through U.S. Pharmacies



10/22/2012 9:40:52 AM

NORTHBROOK, Ill., Oct. 22, 2012 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that MYRBETRIQ (mirabegron) extended-release tablets, indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency, is now available through U.S. pharmacies.

"The availability of MYRBETRIQ marks an important milestone in our ongoing commitment to urology," said Jim Robinson, senior vice president, Astellas Sales and Marketing. "We are pleased to now be able to provide a portfolio of treatment options for those living with overactive bladder."

MYRBETRIQ is a once-daily, oral beta-3 adrenergic agonist discovered and developed by Astellas. Antimuscarinics are the current OAB treatment standard and work by binding to muscarinic receptors in the bladder and inhibiting involuntary bladder contractions.[1] MYRBETRIQ relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 adrenergic receptors which increases bladder capacity.[2]

"Overactive bladder affects millions of Americans," said Dr. Allen Seftel, outreach council chair of the Urology Care Foundation, the official foundation of the American Urological Association. "Treatment can help, and patients should talk to their doctors to find out the treatment options available to them."

MYRBETRIQ was approved by the U.S. Food and Drug Administration (FDA) on June 28, 2012.

The recommended starting dose for MYRBETRIQ is 25 mg once daily with or without food. MYRBETRIQ 25 mg is effective within eight weeks; based on individual efficacy and tolerability, the dose may be increased to 50 mg once daily.[3]

USE of MYRBETRIQ

MYRBETRIQ (mirabegron) is a prescription medicine for adults used to treat overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

IMPORTANT SAFETY INFORMATION

MYRBETRIQ may cause your blood pressure to increase or make your blood pressure worse if you have a history of high blood pressure. It is recommended that your doctor check your blood pressure while you are taking MYRBETRIQ.

MYRBETRIQ may increase your chances of not being able to empty your bladder. Tell your doctor right away if you have trouble emptying your bladder or you have a weak urine stream.

Tell your doctor about all the medicines you take including medications for overactive bladder or other medicines such as thioridazine (Mellaril® and Mellaril S®), flecainide (Tambocor), propafenone (Rythmol®), digoxin (Lanoxin®).* MYRBETRIQ may affect the way other medicines work, and other medicines may affect how MYRBETRIQ works.

Before taking MYRBETRIQ, tell your doctor if you have liver or kidney problems. In clinical studies, the most common side effects seen with MYRBETRIQ included increased blood pressure, common cold symptoms (nasopharyngitis), urinary tract infection and headache.

For further information please talk to your healthcare professional and see accompanying Product Information for MYRBETRIQ (mirabegron).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

*All other trademarks or registered trademarks are the property of their respective owners.

About Overactive Bladder

According to the National Association for Continence, one in five adults has overactive bladder.[4] However, recent studies have found that many more people may be affected, and have not talked to their physicians out of embarrassment or belief that OAB cannot be treated.[5] For people with OAB, inappropriate signals are sent to the muscles in the bladder causing them to contract before the bladder is full. These bladder contractions may cause strong, sudden urges, and a frequent need to go to the bathroom, sometimes without any advance warning.[6] Many patients cope with their symptoms by restricting fluids, carrying extra clothing and "mapping" bathroom locations wherever they go.

About Astellas Urology

Astellas Pharma US, Inc., located in Northbrook, Illinois, is a U.S. 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 company is committed to being a global category leader in urology and providing solutions for physicians and patients through the discovery of new treatments for OAB and other urologic conditions. Astellas currently markets the number one branded OAB treatment in the U.S. For more information about Astellas Pharma US, Inc., please visit www.astellas.us.

[1] Yamaguchi O. Antimuscarinics and Overactive Bladder: Other Mechanism of Action. Neurourology and Urodynamics 2010; 29:112115

[2] MYRBETRIQ Prescribing Information, Section 12.1, June 2012

[3] MYRBETRIQ Prescribing Information, Section 2.1, June 2012

[4] National Association for Continence. Accessed May 29, 2012. http://www.nafc.org/media/media-kit/facts-statistics

[5] Kin S, et al. Medical Visits Among Adults with Symptoms Commonly Associated with an Overactive Bladder. BJU International. 2006;97:551-554.

[6] Abrams P, Cardozo L, Fall M, et al. Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourology & Urodynamics. 2002;21(2):167-78.

SOURCE Astellas Pharma US, Inc.


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