Efficacy

GO with efficacy for incontinence
and micturition frequency1

Study Design: Monotherapy

Myrbetriq® (mirabegron) was evaluated in three 12‑week, double‑blind, randomized, placebo‑controlled, parallel‑group, multicenter clinical trials in patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency (Studies 1, 2, and 3).

MYRBETRIQ (mirabegron) Study Design details

Clinical Studies: Monotherapy

Efficacy demonstrated in three 12-week, double-blind, placebo-controlled Phase III studies1

Drop of water

Fewer episodes of
incontinence

Clock showing hours between events

Reduced micturition
frequency

Beaker

Greater volume
voided

Reduced Incontinence

Myrbetriq® (mirabegron) significantly reduced incontinence episodes per 24 hours1

Co-primary Endpoint

Mean change from baseline to final visit to end treatment (Week 12) in number of incontinence episodes per 24 hours (Full Analysis Set-Incontinence [FAS-I])1*†‡

MYRBETRIQ (mirabegron) Clinical Study Results: Reduced Incontinence

Myrbetriq was effective in treating the symptoms of overactive bladder (OAB):

  • Myrbetriq 25 mg: Within 8 weeks
  • Myrbetriq 50 mg: Within 4 weeks

The efficacy of Myrbetriq 25 mg and 50 mg was maintained through the 12-week treatment period.1

*For incontinence episodes per 24 hours, the analysis population is restricted to patients with ≥1 episode of incontinence at baseline.
Adjusted mean for baseline, gender, and geographic region.
This population includes patients randomized to placebo and Myrbetriq 50 mg in Studies 1 and 2.
Reduced Micturition Frequency

Myrbetriq® (mirabegron) significantly reduced micturition frequency per 24 hours1

Co-primary Endpoint

Mean change from baseline to end of treatment (Week 12) in number of micturitions per 24 hours1*

MYRBETRIQ (mirabegron) Clinical Study Results: Reduced Micturition Frequency

Myrbetriq was effective in treating the symptoms of overactive bladder (OAB):

  • Myrbetriq 25 mg: Within 8 weeks
  • Myrbetriq 50 mg: Within 4 weeks

The efficacy of Myrbetriq 25 mg and 50 mg was maintained through the 12-week treatment period.1

*Adjusted mean for baseline, gender, and geographic region.

Increased Volume Voided

Myrbetriq® (mirabegron) increased the mean volume of urine voided per micturition1*

Secondary Endpoint

Mean change from baseline to end of treatment (Week 12) in volume of urine voided per micturition1*

MYRBETRIQ (mirabegron) Clinical Study Results: Increased Volume Voided
Study 1: Increased Volume Voided Data Over Time
Study 2: Increased Volume Voided Data Over Time
Study 3: Increased Volume Voided Data Over Time

*Adjusted mean for baseline, gender, and geographic region.
Myrbetriq 25 mg did not demonstrate statistical significance for change in volume voided per micturition.

Elderly Patient Subgroup Analysis

Overactive bladder (OAB) Prevalence

  • The prevalence of OAB symptoms increases with age in both men and women2
  • OAB has a prevalence of ~15% among those aged ≥65 and 30–40% among those aged ≥753

Myrbetriq® (mirabegron) Monotherapy in Elderly Patient Populations

Pie chart showing percent of elderly on MYRBETRIQ (mirabegron) by age group
  • Magnifying glass
    No overall differences in safety or effectiveness were observed between patients <65 years and those ≥65 years of age in the Phase II and III studies of Myrbetriq1*
  • Wave
    The pharmacokinetics of Myrbetriq were similar in elderly and younger volunteers1†
  • Up or down
    No dose adjustment is necessary for the elderly1

*Of the 5648 patients who received Myrbetriq in the Phase II and III studies, 2029 (35.9%) were ≥65 years of age. Within that subset, 557 patients (9.9% of the total study population) were ≥75 years of age. All patients were ≥18 years of age.1

The Cmax and area under curve (AUC) of Myrbetriq following multiple oral doses in elderly volunteers (≥65 years) were similar to those in younger volunteers (18 to 45 years).1

To see the safety results, including a subset analysis of elderly patients, click here

For your patients with commercial insurance

Eligible patients can save up to $70 every month for a full year on their Myrbetriq prescription with the Momentum Program Savings Card

Eligibility restrictions, terms and conditions apply. Patient is responsible for the first $20 plus any differential over $90 on each prescription

Learn how your patients can save

INDICATIONS AND USAGE

Myrbetriq® (mirabegron), a beta-3 adrenergic agonist, is indicated as monotherapy or in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

IMPORTANT SAFETY INFORMATION

Do not use Myrbetriq® (mirabegron) in patients who have known hypersensitivity reactions to mirabegron or any component of the tablet.

Solifenacin succinate is contraindicated in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and in patients with hypersensitivity to the product.

Myrbetriq alone or in combination with solifenacin succinate 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 ≥ 180mm Hg and/or diastolic blood pressure ≥ 110mm Hg). Worsening of hypertension was reported infrequently in Myrbetriq clinical trial patients with OAB.

In patients taking Myrbetriq, urinary retention has been reported in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medications for the treatment of OAB. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in Myrbetriq patients; however, Myrbetriq and solifenacin succinate should still be administered with caution to patients with clinically significant BOO. For example, monitor these patients for signs and symptoms of urinary retention. Myrbetriq should also be administered with caution to patients taking antimuscarinic medications for the treatment of OAB, including solifenacin succinate.

Angioedema of the face, lips, tongue and/or larynx has been reported with Myrbetriq and with solifenacin succinate. 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, promptly discontinue Myrbetriq and/or solifenacin succinate and initiate appropriate therapy and/or measures necessary to ensure a patent airway.

Solifenacin succinate should be administered with caution to patients with decreased gastrointestinal motility, controlled narrow-angle glaucoma or reduced renal or hepatic function. Doses of solifenacin succinate higher than 5mg are not recommended in patients with severe renal impairment, moderate hepatic impairment, or when administered with ketoconazole or other potent CYP3A4 inhibitors. Use of solifenacin succinate in patients with severe hepatic impairment is not recommended.

Anticholinergic central nervous system (CNS) effects have been reported with solifenacin succinate 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 solifenacin succinate affects them. If a patient experiences these effects, dose reduction or drug discontinuation should be considered.

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.

In solifenacin succinate monotherapy studies, for the 5mg dose one serious adverse event (angioneurotic edema) was reported. For the 10mg dose, three intestinal serious adverse events were reported (one fecal impaction, one colonic obstruction and one intestinal obstruction).

In clinical trials, the most commonly reported adverse reactions (> 2% and > placebo) for Myrbetriq 25mg and 50mg versus 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%).

In clinical trials, the most commonly reported adverse reactions (> 2% and > placebo and > comparator) for Myrbetriq in combination with solifenacin succinate 25mg + 5mg and 50mg + 5mg versus Myrbetriq 25mg, Myrbetriq 50mg, solifenacin succinate 5mg and placebo, respectively, were dry mouth (9.3%, 7.2% vs. 3.8%, 3.6%, 6.5%, 2.2%), urinary tract infection (7.0%, 4.0% vs. 4.0%, 4.2%, 3.6%, 5.3%), constipation (4.2%, 3.9% vs. 1.2%, 2.8%, 2.4%, 1.2%), and tachycardia (2.2%, 0.9% vs. 1.6%, 1.6%, 0.7%, 0.8%).

In postmarketing experience with mirabegron, the following events have also occurred: atrial fibrillation, nausea, constipation, diarrhea, and dizziness.

Please see accompanying complete Prescribing Information for Myrbetriq® (mirabegron) and VESIcare® (solifenacin succinate).

References

1. Myrbetriq [Prescribing Information]. Northbrook, IL: Astellas Pharma US, Inc. 2. Coyne KS, Sexton CC, Vats V, Thompson C, Kopp ZS, Milsom I. National community prevalence of overactive bladder in the United States stratified by sex and age. Urology. 2011;77(5):1081-7. 3. Wagg A, Cardozo L, Nitti VW, et al. The efficacy and tolerability of the β3-adrenoceptor agonist mirabegron for the treatment of symptoms of overactive bladder in older patients. Age Ageing. 2014:43(5):666-675.

Important Safety Information,
Indications and Usage

INDICATIONS AND USAGE

Myrbetriq® (mirabegron), a beta-3 adrenergic agonist, is indicated as monotherapy or in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

IMPORTANT SAFETY INFORMATION

Do not use Myrbetriq® (mirabegron) in patients who have known hypersensitivity reactions to mirabegron or any component of the tablet.

Solifenacin succinate is contraindicated in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and in patients with hypersensitivity to the product.

Myrbetriq alone or in combination with solifenacin succinate 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 ≥ 180mm Hg and/or diastolic blood pressure ≥ 110mm Hg). Worsening of hypertension was reported infrequently in Myrbetriq clinical trial patients with OAB.

In patients taking Myrbetriq, urinary retention has been reported in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medications for the treatment of OAB. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in Myrbetriq patients; however, Myrbetriq and solifenacin succinate should still be administered with caution to patients with clinically significant BOO. For example, monitor these patients for signs and symptoms of urinary retention. Myrbetriq should also be administered with caution to patients taking antimuscarinic medications for the treatment of OAB, including solifenacin succinate.

Angioedema of the face, lips, tongue and/or larynx has been reported with Myrbetriq and with solifenacin succinate. 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, promptly discontinue Myrbetriq and/or solifenacin succinate and initiate appropriate therapy and/or measures necessary to ensure a patent airway.

Solifenacin succinate should be administered with caution to patients with decreased gastrointestinal motility, controlled narrow-angle glaucoma or reduced renal or hepatic function. Doses of solifenacin succinate higher than 5mg are not recommended in patients with severe renal impairment, moderate hepatic impairment, or when administered with ketoconazole or other potent CYP3A4 inhibitors. Use of solifenacin succinate in patients with severe hepatic impairment is not recommended.

Anticholinergic central nervous system (CNS) effects have been reported with solifenacin succinate 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 solifenacin succinate affects them. If a patient experiences these effects, dose reduction or drug discontinuation should be considered.

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.

In solifenacin succinate monotherapy studies, for the 5mg dose one serious adverse event (angioneurotic edema) was reported. For the 10mg dose, three intestinal serious adverse events were reported (one fecal impaction, one colonic obstruction and one intestinal obstruction).

In clinical trials, the most commonly reported adverse reactions (> 2% and > placebo) for Myrbetriq 25mg and 50mg versus 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%).

In clinical trials, the most commonly reported adverse reactions (> 2% and > placebo and > comparator) for Myrbetriq in combination with solifenacin succinate 25mg + 5mg and 50mg + 5mg versus Myrbetriq 25mg, Myrbetriq 50mg, solifenacin succinate 5mg and placebo, respectively, were dry mouth (9.3%, 7.2% vs. 3.8%, 3.6%, 6.5%, 2.2%), urinary tract infection (7.0%, 4.0% vs. 4.0%, 4.2%, 3.6%, 5.3%), constipation (4.2%, 3.9% vs. 1.2%, 2.8%, 2.4%, 1.2%), and tachycardia (2.2%, 0.9% vs. 1.6%, 1.6%, 0.7%, 0.8%).

In postmarketing experience with mirabegron, the following events have also occurred: atrial fibrillation, nausea, constipation, diarrhea, and dizziness.

Please see accompanying complete Prescribing Information for Myrbetriq® (mirabegron) and VESIcare® (solifenacin succinate).