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Myrbetriq - mirabegron
            ™



  Manufacturer: Astellas Pharma

  FDA Approval Date: 6/28/2012
Myrbetriq™ - mirabegron

         Clinical Application

• Indications:
  • Treatment of overactive bladder (OAB) with
    symptoms of urgency, urge urinary
    incontinence and urinary frequency
• Place in therapy:
  • Patients unable to tolerate anticholinergic
    agents for OAB
  • Patients for whom OAB significantly
    impacts their quality of life
Myrbetriq™ - mirabegron

        Clinical Application

• Warnings/Precautions
  • May elevate blood pressure
  • Use cautiously in patients with bladder
    outlet obstruction or taking antimuscarinic
    agents for OAB
  • Monitor patients taking concomitant
    CYP2D6 object drugs for adverse
    reactions
  • Cautiously initiate and titrate digoxin
Myrbetriq™ - mirabegron

        Clinical Application

• Pregnancy:
  • Category C


• Lactation:
  • Predicted to found in human breast milk
  • Discuss discontinuing nursing or
    mirabegron to minimize potential serious
    adverse effects to nursing infant
Myrbetriq™ - mirabegron

               Drug Facts

• Pharmacology
  • Beta3 adrenergic agonist
  • Agonizes beta3 receptors of the bladder
    detrusor muscle leading to relaxation
  • Minimal intrinsic activity on beta1 and beta2
Myrbetriq™ - mirabegron

               Drug Facts

• Pharmacokinetics
  • A – Bioavailability: 25-35%;
  • D – Vd: 1670L; 70% protein bound
  • M – Hepatic via dealkylation, amide
    hydrolysis, glucuronidation, oxidation,
    CYP2D6 (minor) CYP3A4 (minor)
  • E – 55% urine (25% unchanged); 35%
    feces; t½: 50hr
Myrbetriq™ - mirabegron

          Drug Interactions

• Drug Interactions – Object Drugs
  • Metoprolol (↑AUC 229%)
  • Desipramine (↑AUC 241%)
  • As a moderate CYP2D6 inhibitor, monitoring
    of narrow therapeutic index drugs should be
    considered when starting mirabegron
    • Thioridazine, flecainide, propafenone
Myrbetriq™ - mirabegron

          Drug Interactions

• Drug Interactions – Precipitant Drugs
  • No significant interactions
Myrbetriq™ - mirabegron

                 Adverse Effects

• Common Adverse Effects
   Adverse Effect         Mirabegron   Mirabegron   Placebo
                           25mg (%)     50mg (%)       (%)
    Hypertension             11.3         7.5         7.6
Urinary Tract Infection      4.2          2.9         1.8
   Nasopharyngitis           3.5          3.9         2.5
      Headache               2.1          3.2         3.0
Myrbetriq™ - mirabegron

     Monitoring Parameters

• Efficacy Monitoring
  • Decrease in incontinence episodes
  • Decrease in micturitions / day
• Toxicity Monitoring
  • Pulse
  • Blood Pressure
Myrbetriq™ - mirabegron

    Prescription Information

• Dosing
  • 25mg daily for 8 weeks, then 50mg daily
• Cost
  • Expected to be available mid-October 2012
Myrbetriq™ - mirabegron

   Literature Review: Scorpio

• Randomized double-blind, placebo- and
  active-controlled, European/Australian
  trial
• 2 week placebo run-in period followed
  by 12 week treatment period
• 1987 patients randomized equally to
  placebo, mirabegron 50mg, mirabegron
  100mg or tolterodine SR 4mg
 US FDA Myrbetriq NDA 2011
Myrbetriq™ - mirabegron

      Literature Review: Scorpio

• Inclusion Criteria:
  •   Mean age: 60 years
  •   99.1% White
  •   72.2% female
  •   Mean BMI: 27.8 kg/m2
  •   62.9% <65 years old
  •   > 8 micturitions/24hrs AND >3 episodes of
      urgency with or without incontinence/24hrs

 US FDA Myrbetriq NDA 2011
Myrbetriq™ - mirabegron

   Literature Review: Scorpio

• Primary Endpoints
  • Change in mean number of micturitions/
    24hrs at final visit
  • Change in mean number of incontinence
    episodes/24hrs at final visit
• Secondary Endpoints
  • Change in mean volume voided/micturition
  • Primary endpoints at week 4
  • Postvoid residual volume (PVR)
 US FDA Myrbetriq NDA 2011
Myrbetriq™ - mirabegron

    Literature Review: Scorpio

     Mean Number of Micturitions per 24 hours
                  at final visit

                  Mirabegron   Mirabegron   Tolterodine
                     50mg        100mg       SR 4mg
Adj. mean diff.
  vs placebo         -0.60        -0.44        -0.25
from baseline

   p-value         p<0.001       p=0.005        NS



 US FDA Myrbetriq NDA 2011
Myrbetriq™ - mirabegron

    Literature Review: Scorpio

   Mean Number of Incontinence Episodes per 24
               hours at final visit

                  Mirabegron   Mirabegron   Tolterodine
                     50mg        100mg       SR 4mg
Adj. mean diff.
  vs placebo         -0.41        -0.29        -0.10
from baseline

   p-value         p=0.003       p=0.01         NS



 US FDA Myrbetriq NDA 2011
Myrbetriq™ - mirabegron

    Literature Review: Scorpio

      Mean Volume Voided (mL) per Micturition
                   at final visit

                  Mirabegron   Mirabegron   Tolterodine
                     50mg        100mg       SR 4mg
Adj. mean diff.
  vs placebo         11.9         13.2         12.6
from baseline

   p-value         p<0.001       p<0.001      p<0.001



 US FDA Myrbetriq NDA 2011
Myrbetriq™ - mirabegron

   Literature Review: Scorpio

• Conclusions
  • Mirabegron demonstrated greater efficacy
    than placebo for the primary endpoints
  • The improvement seen with tolterodine was
    less than expected, which may be attributed
    to prior failure with antimuscarinic agents
  • Older patients (> 65 years) showed a better
    treatment effect than younger patients


 US FDA Myrbetriq NDA 2011
Myrbetriq™ - mirabegron

                    Summary

• Myrbetriq, mirabegron, is a beta3 agonist for the
  treatment of overactive bladder
• Dosage adjustments are recommended in patients
  with moderate hepatic or renal impairment
• Caution should be taken in patients with HTN
• Place in therapy includes patients with significantly
  impaired quality of life due to OAB who are unable
  to tolerate anticholinergic agents
Myrbetriq™ - mirabegron

                 References
1.   www.myrbetriq.com
2.   Include all article references in standard format.
3.   U.S. Food and Drug Administration, Center for
     Drug Evaluation and Research. Myrbetriq NDA
     202611 Medical Review, August 26, 2011.
     Retrieved August 24, 2012 from
     http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012

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Mirabegron

  • 1. Myrbetriq - mirabegron ™ Manufacturer: Astellas Pharma FDA Approval Date: 6/28/2012
  • 2. Myrbetriq™ - mirabegron Clinical Application • Indications: • Treatment of overactive bladder (OAB) with symptoms of urgency, urge urinary incontinence and urinary frequency • Place in therapy: • Patients unable to tolerate anticholinergic agents for OAB • Patients for whom OAB significantly impacts their quality of life
  • 3. Myrbetriq™ - mirabegron Clinical Application • Warnings/Precautions • May elevate blood pressure • Use cautiously in patients with bladder outlet obstruction or taking antimuscarinic agents for OAB • Monitor patients taking concomitant CYP2D6 object drugs for adverse reactions • Cautiously initiate and titrate digoxin
  • 4. Myrbetriq™ - mirabegron Clinical Application • Pregnancy: • Category C • Lactation: • Predicted to found in human breast milk • Discuss discontinuing nursing or mirabegron to minimize potential serious adverse effects to nursing infant
  • 5. Myrbetriq™ - mirabegron Drug Facts • Pharmacology • Beta3 adrenergic agonist • Agonizes beta3 receptors of the bladder detrusor muscle leading to relaxation • Minimal intrinsic activity on beta1 and beta2
  • 6. Myrbetriq™ - mirabegron Drug Facts • Pharmacokinetics • A – Bioavailability: 25-35%; • D – Vd: 1670L; 70% protein bound • M – Hepatic via dealkylation, amide hydrolysis, glucuronidation, oxidation, CYP2D6 (minor) CYP3A4 (minor) • E – 55% urine (25% unchanged); 35% feces; t½: 50hr
  • 7. Myrbetriq™ - mirabegron Drug Interactions • Drug Interactions – Object Drugs • Metoprolol (↑AUC 229%) • Desipramine (↑AUC 241%) • As a moderate CYP2D6 inhibitor, monitoring of narrow therapeutic index drugs should be considered when starting mirabegron • Thioridazine, flecainide, propafenone
  • 8. Myrbetriq™ - mirabegron Drug Interactions • Drug Interactions – Precipitant Drugs • No significant interactions
  • 9. Myrbetriq™ - mirabegron Adverse Effects • Common Adverse Effects Adverse Effect Mirabegron Mirabegron Placebo 25mg (%) 50mg (%) (%) Hypertension 11.3 7.5 7.6 Urinary Tract Infection 4.2 2.9 1.8 Nasopharyngitis 3.5 3.9 2.5 Headache 2.1 3.2 3.0
  • 10. Myrbetriq™ - mirabegron Monitoring Parameters • Efficacy Monitoring • Decrease in incontinence episodes • Decrease in micturitions / day • Toxicity Monitoring • Pulse • Blood Pressure
  • 11. Myrbetriq™ - mirabegron Prescription Information • Dosing • 25mg daily for 8 weeks, then 50mg daily • Cost • Expected to be available mid-October 2012
  • 12. Myrbetriq™ - mirabegron Literature Review: Scorpio • Randomized double-blind, placebo- and active-controlled, European/Australian trial • 2 week placebo run-in period followed by 12 week treatment period • 1987 patients randomized equally to placebo, mirabegron 50mg, mirabegron 100mg or tolterodine SR 4mg US FDA Myrbetriq NDA 2011
  • 13. Myrbetriq™ - mirabegron Literature Review: Scorpio • Inclusion Criteria: • Mean age: 60 years • 99.1% White • 72.2% female • Mean BMI: 27.8 kg/m2 • 62.9% <65 years old • > 8 micturitions/24hrs AND >3 episodes of urgency with or without incontinence/24hrs US FDA Myrbetriq NDA 2011
  • 14. Myrbetriq™ - mirabegron Literature Review: Scorpio • Primary Endpoints • Change in mean number of micturitions/ 24hrs at final visit • Change in mean number of incontinence episodes/24hrs at final visit • Secondary Endpoints • Change in mean volume voided/micturition • Primary endpoints at week 4 • Postvoid residual volume (PVR) US FDA Myrbetriq NDA 2011
  • 15. Myrbetriq™ - mirabegron Literature Review: Scorpio Mean Number of Micturitions per 24 hours at final visit Mirabegron Mirabegron Tolterodine 50mg 100mg SR 4mg Adj. mean diff. vs placebo -0.60 -0.44 -0.25 from baseline p-value p<0.001 p=0.005 NS US FDA Myrbetriq NDA 2011
  • 16. Myrbetriq™ - mirabegron Literature Review: Scorpio Mean Number of Incontinence Episodes per 24 hours at final visit Mirabegron Mirabegron Tolterodine 50mg 100mg SR 4mg Adj. mean diff. vs placebo -0.41 -0.29 -0.10 from baseline p-value p=0.003 p=0.01 NS US FDA Myrbetriq NDA 2011
  • 17. Myrbetriq™ - mirabegron Literature Review: Scorpio Mean Volume Voided (mL) per Micturition at final visit Mirabegron Mirabegron Tolterodine 50mg 100mg SR 4mg Adj. mean diff. vs placebo 11.9 13.2 12.6 from baseline p-value p<0.001 p<0.001 p<0.001 US FDA Myrbetriq NDA 2011
  • 18. Myrbetriq™ - mirabegron Literature Review: Scorpio • Conclusions • Mirabegron demonstrated greater efficacy than placebo for the primary endpoints • The improvement seen with tolterodine was less than expected, which may be attributed to prior failure with antimuscarinic agents • Older patients (> 65 years) showed a better treatment effect than younger patients US FDA Myrbetriq NDA 2011
  • 19. Myrbetriq™ - mirabegron Summary • Myrbetriq, mirabegron, is a beta3 agonist for the treatment of overactive bladder • Dosage adjustments are recommended in patients with moderate hepatic or renal impairment • Caution should be taken in patients with HTN • Place in therapy includes patients with significantly impaired quality of life due to OAB who are unable to tolerate anticholinergic agents
  • 20. Myrbetriq™ - mirabegron References 1. www.myrbetriq.com 2. Include all article references in standard format. 3. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Myrbetriq NDA 202611 Medical Review, August 26, 2011. Retrieved August 24, 2012 from http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012