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Astellas Pharma US Release: Data on MYRBETRIQ® (mirabegron) as Treatment for Overactive Bladder Presented at American Urological Association 2013


5/8/2013 7:06:11 AM

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SAN DIEGO, May 7, 2013 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that results of three studies of MYRBETRIQ® (mirabegron) as a treatment for overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency were presented in poster sessions at the American Urological Association Annual (AUA) Meeting in San Diego.

The first two studies demonstrated the efficacy and tolerability of MYRBETRIQ via separate prospective pooled analyses of three randomized Phase 3 trials. The third study, the 12-week Phase 2 Symphony trial, assessed combination therapy of MYRBETRIQ and VESIcare® (solifenacin succinate) versus VESIcare alone.

"The pooled analyses represent an important body of evidence supporting MYRBETRIQ as a potential treatment option for OAB symptoms of urge urinary incontinence, urgency and urinary frequency," said Shontelle Dodson, PharmD, Senior Director, Astellas Scientific and Medical Affairs.

About MYRBETRIQ

MYRBETRIQ was approved by the U.S. Food and Drug Administration (FDA) on June 28, 2012, and is indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency and urinary frequency. Mirabegron is also approved for use in Japan, the European Union and Canada.

Indications and Usage for MYRBETRIQ

MYRBETRIQ (mirabegron) is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.

IMPORTANT SAFETY INFORMATION for MYRBETRIQ

  • Myrbetriq can increase blood pressure. Periodic blood pressure determinations are recommended, especially in hypertensive patients. Myrbetriq is not recommended for use in severe uncontrolled hypertensive patients (defined as systolic blood pressure greater than or equal to 180mm Hg and/or diastolic blood pressure greater than or equal to 110 mm Hg).
  • Urinary retention in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medications for the treatment of OAB has been reported in postmarketing experience in patients taking mirabegron. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in Myrbetriq patients; however, Myrbetriq should be administered with caution to patients with clinically significant BOO. Myrbetriq should also be administered with caution to patients taking antimuscarinic medications for the treatment of OAB.
  • Since Myrbetriq is a moderate CYP2D6 inhibitor, the systemic exposure to CYP2D6 substrates such as metoprolol and desipramine is increased when co-administered with Myrbetriq. Therefore, appropriate monitoring and dose adjustment may be necessary, especially with narrow therapeutic index drugs metabolized by CYP2D6, such as thioridazine, flecainide, and propafenone.
  • Most commonly reported adverse reactions (>2% and >placebo) for Myrbetriq 25 mg and 50 mg vs placebo, respectively, were hypertension (11.3%, 7.5% vs 7.6%), nasopharyngitis (3.5%, 3.9% vs 2.5%), urinary tract infection (4.2%, 2.9% vs 1.8%), and headache (2.1%, 3.2% vs 3.0%).

For full Prescribing Information for Myrbetriq, please visit www.Myrbetriq.com.

Indications and Usage for VESIcare®

VESIcare is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.

IMPORTANT SAFETY INFORMATION for VESIcare®

  • VESIcare is contraindicated in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and in patients with hypersensitivity to the product.
  • Angioedema of the face, lips, tongue and/or larynx have been reported with VESIcare. Cases of angioedema have been reported to occur hours after the first dose or after multiple doses. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, VESIcare should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided. Anaphylactic reactions have been reported rarely in patients treated with VESIcare. VESIcare should not be used in patients with a known or suspected hypersensitivity to solifenacin succinate. In patients who develop anaphylactic reactions, VESIcare should be discontinued and appropriate therapy and/or measures should be taken.
  • VESIcare should be administered with caution to patients with bladder outflow obstruction, decreased gastrointestinal motility, controlled narrow-angle glaucoma, or reduced renal or hepatic function. Doses of VESIcare higher than 5 mg are not recommended in patients with severe renal impairment, moderate hepatic impairment, or when administered with ketoconazole or other potent CYP3A4 inhibitors. Use of VESIcare in patients with severe hepatic impairment is not recommended.
  • Anticholinergic central nervous system (CNS) effects have been reported with VESIcare use, including headache, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing dose, and be advised not to drive or operate heavy machinery until they know how VESIcare affects them. If a patient experiences these effects, dose reduction or drug discontinuation should be considered.
  • In placebo-controlled studies, for the 10-mg dose, three intestinal serious adverse events were reported (one fecal impaction, one colonic obstruction, and one intestinal obstruction). For the 5-mg dose, one serious adverse event (angioneurotic edema) was reported.
  • In placebo-controlled studies, the most common adverse events reported by patients were dry mouth (10.9%, 27.6%, 4.2%), constipation (5.4%, 13.4%, 2.9%), blurred vision (3.8%, 4.8%, 1.8%), and urinary tract infection (2.8%, 4.8%, 2.8%) with VESIcare 5 mg, 10 mg, and placebo, respectively.

For complete prescribing information for VESIcare, go to www.vesicare.com.

About Overactive Bladder

According to the National Association for Continence, one in five adults has overactive bladder. 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. 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. Many patients manage their symptoms by restricting fluids, carrying extra clothing and "mapping" bathroom locations wherever they go.

About Astellas

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 organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. For more information about Astellas Pharma US, Inc., please visit our website at www.astellas.us.

Abstract 1372: May 6, 2012 at 3:30 p.m. PT

Abstract 1957: May 7, 2013 at 3:30 p.m. PT

Abstract 1958: May 7, 2013 at 3:30 p.m. PT

SOURCE Astellas Pharma US, Inc.

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