Efficacy

Myrbetriq® (mirabegron) demonstrated efficacy
for incontinence and urinary frequency1

Study Design

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).

Entry Criteria

  • OAB symptoms for ≥3 months
  • ≥8 micturitions per day
  • ≥3 episodes of urgency with or without incontinence over a 3 day period

Efficacy endpoints in Studies 1, 2, and 3

Change from baseline to end of treatment (Week 12) in:

  • Mean number of incontinence episodes per 24 hours (co‑primary)
  • Mean number of micturitions
    per 24 hours, based on a 3 day micturition diary (co‑primary)
  • Mean volume voided per micturition (secondary)

Clinical Studies

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

Droplet icon

Fewer episodes of
incontinence

Clock icon

Reduced micturition
frequency

Beaker Icon

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 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 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*

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

Elderly Patients

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) in Elderly Patient Populations

  • 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*
  • The pharmacokinetics of Myrbetriq were similar in elderly and younger volunteers1†
  • 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) 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

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

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

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 ≥ 180 mm Hg and/or diastolic blood pressure ≥ 110 mm 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 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.

Angioedema of the face, lips, tongue and/or larynx has been reported with Myrbetriq. In some cases angioedema occurred after the first dose. 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 initiate appropriate therapy and/or measures necessary to ensure a patent airway.

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. Appropriate monitoring and dose adjustment may be necessary, especially with narrow therapeutic index drugs metabolized by CYP2D6, such as thioridazine, flecainide, and propafenone.

In clinical trials, the most commonly reported adverse reactions (> 2% and > placebo) for Myrbetriq 25 mg and 50 mg 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 postmarketing experience, the following events have also occurred: atrial fibrillation, nausea, constipation, diarrhea, and dizziness.

Please see accompanying complete Prescribing Information for Myrbetriq® (mirabegron).

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) 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

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

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

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 ≥ 180 mm Hg and/or diastolic blood pressure ≥ 110 mm 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 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.

Angioedema of the face, lips, tongue and/or larynx has been reported with Myrbetriq. In some cases angioedema occurred after the first dose. 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 initiate appropriate therapy and/or measures necessary to ensure a patent airway.

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. Appropriate monitoring and dose adjustment may be necessary, especially with narrow therapeutic index drugs metabolized by CYP2D6, such as thioridazine, flecainide, and propafenone.

In clinical trials, the most commonly reported adverse reactions (> 2% and > placebo) for Myrbetriq 25 mg and 50 mg 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 postmarketing experience, the following events have also occurred: atrial fibrillation, nausea, constipation, diarrhea, and dizziness.

Please see accompanying complete Prescribing Information for Myrbetriq® (mirabegron).