Enablex

Please see Selected Safety Information for ENABLEX® on slide 62, and Full Prescribing Information, which includes the Patient Information, provided by your sales representative and at www.enablex.com.PROPRIETARY AND CONFIDENTIAL - NOT TO BE COPIED, DISTRIBUTED, OR USED IN DETAILING

Please see Selected Safety Information for ENABLEX® on slide 66 and Full Prescribing Information, which includes the Patient Information, provided by your sales representative and at www.enablex.com.PROPRIETARY AND CONFIDENTIAL - NOT TO BE COPIED, DISTRIBUTED, OR USED IN DETAILING

ENABLEX® in the Treatment of Overactive Bladder

ENABLEX® is a registered trademark of Warner Chilcott Company, LLC.

ENABLEX® (darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency

Please see Selected Safety Information for ENABLEX® on slide 66, and Full Prescribing Information, which includes the Patient Information, provided by your sales representative and at www.enablex.com.PROPRIETARY AND CONFIDENTIAL - NOT TO BE COPIED, DISTRIBUTED, OR USED IN DETAILING 2

Presenter

David C. Chaikin, MD, FACSClinical Assistant Professor of Urology

New York-Presbyterian/Weill Cornell Medical CenterNew York, New York

Attending UrologistMorristown Memorial Hospital


Table of Contents



Overactive BladderBackground: Disease State and Epidemiology


Coyne KS, et al. Urology. 2011; 77:1081-1087.

Overactive Bladder Is a Complex Syndrome

5

Urgency 12.6%

Urge Urinary Incontinence

9.1%

Urgency + Frequency

5.2%1.2%

Urgency + Urge Urinary Incontinence

13.1%

Urgency + Urge Urinary

Incontinence + Frequency

7.0%

Prevalence of Overactive Bladder Symptoms in Poll of 2000 Adults Aged ≥40 Years

Urge Urinary Incontinence +

Frequency


Overactive Bladder Affects Over 33 Million Americans

According to the National Overactive Bladder Evaluation (NOBLE) Program

Kelleher CJ. Eur Urol Suppl. 2002;1:11-16.

*Overactive bladder dry: ≥4 episodes of urgency during the preceding 4 weeks and either frequency of >8 voids per day or the use of ≥1 coping behaviors to control bladder function.

†Overactive bladder wet: same criteria as overactive bladder dry, plus ≥3 episodes of urinary incontinence in the past 4 weeks that could not be explained by stress symptoms.

6

21.2 million (10.5% of the US adult population)

12.2 million (6.1% of the US

adult population)

Incontinent(overactive bladder wet†)

Continent(overactive bladder dry*)


Overactive Bladder Risk Factors

*Include elevated body mass index (BMI) and diabetes.

1.Stewart WF, et al. World J Urol. 2003;20:327-336.2.Teleman PM, et al. BJOG. 2004;111:600-604.3.Rosenberg MT, et al. Cleve Clin J Med. 2007;74(suppl 3):S21-S29.4.Thüroff JW, et al. Eur Urol. 2011;59:387-400.

Increased Age1

Abnormal Metabolic Factors2*

Medications3

Pregnancy and Vaginal

Delivery (Women)4

Prostate-related

Conditions (Men)3,4

Pelvic Surgery3


Comorbidities Associated With Overactive Bladder

Falls and Fractures

DepressionSleep

Disturbances

Urinary Tract and Skin

Infections

Brown JS, et al. Am J Manag Care. 2000;6(suppl 11):S574-S579.


Overactive Bladder Negatively Affects QOL

*A standardized questionnaire that measures health-related QOL.

Modified from Stewart WF, et al. World J Urol. 2003;20:327-336.

Dec

reas

e in

M

ean

SF-3

6 Sc

ore

(%)

Patients With Overactive Bladder Urge Incontinence Compared With Controls (SF-36)*

9

QOL Areas of Measure


Treatment Options: Pharmacologic andNon-Pharmacologic Therapies

Non-Pharmacologic (Behavioral Therapy)2

Lifestyle management•Limiting excessive water or caffeine intake

Bladder training•Increasing bladder capacity through lengthening of the voiding interval

Physical therapy•Pelvic floor exercises•Biofeedback therapy

Toileting assistance•Timed and patterned toileting guidance

1. Thüroff JW, et al. Eur Urol. 2011;59:387-400.2. Yamaguchi O, et al. Int J Urol. 2009;16:126-142.

Pharmacologic Therapy1*

• Antimuscarinic drugs

• Drugs acting on membrane channels

• Antidepressants

• Alpha-adrenoreceptor antagonists

• Beta-adrenoreceptor antagonists

• Phosphodiesterase type-5 inhibitors (in men)

• Cyclo-oxygenase (COX) inhibitors

• Hormones

*Recommendations for pharmacologic therapy are from the European Association of Urology (EAU) guidelines for incontinence.

10


M3 Receptor Selectivity Allows for Targeting of Tissue of Intent

Abrams P, et al. Br J Pharmacol. 2006;148:565-578.


Targets for Muscarinic Receptor Inhibition

1. Abrams P, et al. Br J Pharmacol. 2006;148:565-578.2. Sarria B, et al. Am J Physiol Lung Cell Mol Physiol. 2002;283:L1125-L1132.

Cerebral cortexHippocampusEyesSalivary glands

Cardiac muscleEyesSmooth muscle (bronchus)HippocampusHind brain

Impacts:Memory, cognitive function,saliva, tear secretion

Impacts:Heart rate,tear secretion,bronchodilation

Smooth muscle (bladder, bowel)

Salivary glandsEyesBrain

Impacts:Bladder contraction,*bowel motility, saliva,tear secretion,visual accommodation


M3-specific Targeted Therapy for Overactive Bladder• High affinity for the M3 receptor1-3

– Targets the smooth muscle to minimize leaks and accidents1

– Minimizes potential CNS- and CV-related side effects2,3

• M3-selective antagonists do not significantly affect memory3 – Compared with placebo– Significant memory deterioration has been demonstrated

with less-selective agents, such as oxybutynin

1. Abrams P, et al. Br J Pharmacol. 2006;148:565-578.2. Lipton RB, et al. J Urol. 2005;173:493-498.3. Kay G, et al. Eur Urol. 2006;50:317-326.

CNS=central nervous system; CV=cardiovascular.


ENABLEX®: Muscarinic Receptor Selectivity

• M3 receptors are the primary mediators of detrusor contractility in the bladder1

• M3 receptors are also involved in gastrointestinal smooth-muscle contraction, saliva production, and iris sphincter function1,2

14

NA=not available.1. Abrams P, et al. Br J Pharmacol. 2006;148:565-578.2. ENABLEX® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011.3. Geriatric Consultant Resources LLC. http://www.gcrweb.com/OABdss/comprehensive/comp-02a-muscar.htm. Accessed March 25, 2011.


Likelihood of Muscarinic Agents Crossing the BBB

1. Lipton RB, et al. J Urol. 2005;173:493-498.2. Kay G, et al. Clin Ther. 2005;27:127-138.3. VESIcare® [package insert]. Deerfield, IL: Astellas Pharma US, Inc; 2011.4. Geriatric Consultant Resources, LLC. http://www.gcrweb.com/OABdss/comprehensive/comp-02b-pham.htm. Accessed March 23, 2011.

• Less-selective agents have been associated with more impairment of cognitive function1

BBB= blood-brain barrier. *kDa=kiloDalton.



ENABLEX® as a Treatment Option for Patients With Overactive BladderProven Efficacy and Safety by Clinical Trials


ENABLEX®:Prescribing Information

• ENABLEX® (darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency

ENABLEX® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011.

Indication and Usage




• ENABLEX® (darifenacin) extended-release tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. ENABLEX® is also contraindicated in patients with known hypersensitivity to the drug or any of its ingredients


Contraindications





• ENABLEX® (darifenacin) extended-release tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. ENABLEX® is also contraindicated in patients with known hypersensitivity to the drug or any of its ingredients


Contraindications

ENABLEX® should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention; gastrointestinal obstructive disorders because of the risk of gastric retention; severe constipation, ulcerative colitis, or myasthenia gravis. In patients being treated for narrow-angle glaucoma, ENABLEX® should be used with caution and only where the potential benefits outweigh the risks.

Angioedema of the face, lips, tongue, and/or larynx have been reported with darifenacin, in some cases, after the first dose. Angioedema associated with upper airway swelling may be life threatening. Patients should be advised to promptly discontinue darifenacin therapy and seek immediate medical attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing.



• ENABLEX® has been evaluated in 3 randomized, fixed-dose, placebo-controlled, multicenter, double-blind, 12-week studies and 1 randomized, double-blind, placebo-controlled, multicenter, dose-titration study

• In clinical studies, dry mouth and constipation were the most commonly reported adverse events (AEs)




ENABLEX®: Effective Treatment for Overactive Bladder

1. ENABLEX® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011.2. Serra DB, et al. J Clin Pharmacol. 2005;45:1038-1047.3. Haab F, et al. BJU Int. 2006;98:1025-1032.


Chapple C, et al. BJU Int. 2005;95:993-1001.

ENABLEX® Pooled Analysis of Phase 3 Studies

0 2 6 12

ENABLEX® 7.5 mg Once Daily (n=337)

Placebo Once Daily (n=388)

Up to 4 weeks(as needed)

Study Visits (weeks)

Washout Treatments

ENABLEXENABLEX®® 15 mg Once Daily (n=334) 15 mg Once Daily (n=334)

Rand

omiz

ation

Primary Efficacy Change in number of incontinence episodes per week

Secondary Efficacy Number of significant leaks per week

Voiding frequency

Bladder capacity

Frequency and severity of urgency

Number of nocturnal awakenings caused by overactive bladder

Subject population similar between treatment arms

Symptoms of overactive bladder

≥6 months

3 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Fixed-dose, 12-week Studies


7.5 mg ENABLEX® Significantly Reduces Incontinence Episodes by ~70%

23

Chapple C, et al. BJU Int. 2005;95:993-1001.*P=.004 vs placebo; data missing for 2 subjects.

Treatment

Darifenacin 7.5 mg* Placebo

Data from a pooled analysis of 3 phase 3, fixed-dose, double-blind, placebo-controlled, parallel-group, 12-week clinical trials (1001, 1002, 1041). A total of 1059 subjects were included in the analysis (darifenacin 7.5 mg: n=337; darifenacin 15 mg: n=334; placebo: n=388). Absolute changes from baseline (last observation carried forward [LOCF]) to Week 12 for subjects on darifenacin: number of weekly incontinence episodes: –8.8 (7.5 mg) and –10.6 (15 mg).

n=335 n=271


15 mg ENABLEX® Significantly Reduces Incontinence Episodes by >75%

24


*P<.001 vs placebo; data missing for 4 subjects.

Treatment

Darifenacin 15 mg* Placebo

Data from a pooled analysis of 3 phase 3, fixed-dose,double-blind, placebo-controlled, parallel-group, 12-week clinical trials (1001, 1002, 1041). A total of 1059 subjects were included in the analysis (darifenacin 7.5 mg: n=337; darifenacin 15 mg: n=334; placebo: n=388). Absolute changes from baseline (last observation carried forward [LOCF]) to Week 12 for subjects on darifenacin: number of weekly incontinence episodes: –8.8 (7.5 mg) and –10.6 (15 mg).

n=330 n=384


7.5 mg ENABLEX® Significantly Reduces the Number of Urgency Episodes

25


*P<.005 compared with corresponding placebo.

37%

24%


15 mg ENABLEX® Significantly Reduces the Number of Urgency Episodes

26


39%

23%

*P<.01 compared with corresponding placebo.

*

49%

34%

*


ENABLEX® Is Well-tolerated

27

UTI=urinary tract infection.1. ENABLEX® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011.2. Chapple C, et al. BJU Int. 2005;95:993-1001.

Treatment-emergent AEs (TEAEs) Over 1 Year1,2


Few Discontinuations Over 12 Weeks

28



ENABLEX® Long-term Efficacy Up to 2 Years

Haab F, et al. BJU Int. 2006;98:1025-1032.

ENABLEXENABLEX® 7.5 mg Once Daily 7.5 mg Once Daily

12-week Studies Long-term Study (24 months)

ENABLEXENABLEX® 15 mg Once Daily 15 mg Once Daily

ENAB

LEX®

7.5

m

g

for

2

Wee

ks

Study 1 (n=526)ENABLEX® 3.75, 7.5, 15 mg, and Placebo

Study 2 (n=357)ENABLEXENABLEX®® 7.5, 15 mg, and Placebo

Multicenter, Long-term, Noncomparative, Open-label Study

Subjects recruited from 1 of 2 phase 3, randomized, double-blind, 12-week studies

Primary Objective

Assess long-term safety and tolerability

Secondary Objective

Evaluate long-term efficacy

29


ENABLEX® Significantly Reduces Incontinence Episodes Up to 2 Years

Treatment Duration (months)1. Haab F, et al. BJU Int. 2006;98:1025-1032.2. Hill S, et al. Curr Med Res Opin. 2007;23:2697-2704.

Results from an open-label, nonrandomized, multicenter, 2-year extension study. Subjects were enrolled from two 12-week, phase 3, double-blind,

placebo-controlled pivotal trials1,2

30

P<.001 vs pivotal study baseline

n=667 n=598 n=541 n=495 n=464


Low Discontinuation Rates Through 2 Years

31

1. Haab F, et al. BJU Int. 2006;98:1025-1032.2. Haab F, et al. Eur Urol. 2004;45:420-429.3. Steers W, et al. BJU Int. 2005;95:580-586.

Most commonly reported TEAEs were similar to pivotal studies and included dry mouth, constipation, dyspepsia, and headache1-3


PPBC=Patient Perception of Bladder Condition.Zinner N, et al. Int J Clin Pract. 2008;62:1664-1674.

Primary Efficacy

Change in PPBC score from baseline to end of study

Secondary Efficacy

Micturition frequency

Urgency

Urge urinary incontinence episodes after 2, 6, and 12 weeks of treatment compared with baseline

• Subjects were ENABLEX®-naïve and reported lack of sufficient effect and/or AEs on previous treatments with either oxybutynin or tolterodine

ENABLEXENABLEX® 7.5 mg Once Daily (n=180) 7.5 mg Once Daily (n=180)

2-3 weeks

Screening/WashoutTreatments

(optional dose escalation after 2 weeks)

ENABLEXENABLEX® 15 mg Once Daily (n=302) 15 mg Once Daily (n=302)

Baseline1 week 10 weeks

ENABLEX® 7.5 mg Once Daily

(n=497)Enrollment (n=500)

2 weeks

12-Week, Open-label, Single-arm, Multicenter Study

Efficacy in Subjects on Previous Overactive Bladder Therapy


ENABLEX® Significantly* Improves Patient -reported Bladder Control

33

Zinner N, et al. Int J Clin Pract. 2008;62:1664-1674.

Results of PPBC

p <0.0001.


ENABLEX®: Cognitive Function in Older Subjects

Kay G, et al. Eur Urol. 2006;50:317-326.

0 1 2 3

Cognitive Function

Tests (weeks)

Washout Treatments

Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, 3-week Study

Primary Efficacy

Effect on recent (delayed) memory using Name-Face Association Test at Week 3

Secondary Efficacy

Recall on First-Last Name Association Test

Misplaced Objects Test

Delayed recall scores at weeks 1 and 2

Effects on immediate memory

Visual attention

Information processing

Psychomotor/reaction time

34


ENABLEX®: Memory Sparing

*P<.05 vs placebo;†P<.05 vs ENABLEX® (ANCOVA, adjusted for baseline score, age, and gender).ANCOVA=analysis of covariance.

Kay G, et al. Eur Urol. 2006;50:317-326.

• No significant effects on memory

®

* †

35

* †


ENABLEX®:Effect on QT Interval

QTcF=Fridericia-corrected QT interval.

Serra DB, et al. J Clin Pharmacol. 2005;45:1038-1047.


Moxifloxacin 400 mg Once Daily (n=48)Moxifloxacin 400 mg Once Daily (n=48)

Treatment Period (Days 1-6)


Plac

ebo

Run-

in (D

ay –

1)

Placebo (n=47)Placebo (n=47)

7-Day, Single-center, Randomized, Parallel-group Study in Healthy Subjects

Primary Efficacy

Change from mean baseline in QTcF at Tmax

Secondary Efficacy

Mean change from baseline in QT/QTcF

Maximum QT interval postdose change from baseline


ENABLEX®:Minimal Effect on QT Interval

• No significant changes occurred when ENABLEX® was given at 75 mg (10 times the starting dose)

Serra DB, et al. J Clin Pharmacol. 2005;45:1038-1047.

Change From Baseline in Mean QTcF at Tmax (ms)

Placebo (n=44) –2.6

ENABLEX® 15 mg (n=46) –2.6


Efficacy

• Significant reduction in number of incontinence and urgency episodes per week1

• Overactive bladder symptoms significantly improved in subjects who were dissatisfied with prior antimuscarinic therapy2

Specificity

• Strong affinity for M3 receptors3

• No significant effects on delayed or immediate recall memory in older subjects4

• No significant change in QTcF5

Well Studied

• 2-year extension study demonstrated a favorable safety, tolerability, and efficacy profile6,7

• In subjects ≥65 years of age, ENABLEX® was well tolerated; no overall differences in safety or efficacy were observed3,7

1. Chapple C, et al. BJU Int. 2005;95:993-1001.2. Zinner N, et al. Int J Clin Pract. 2008;62:1664-1674.3. ENABLEX® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011.4. Kay G, et al. Eur Urol. 2006;50:317-326.5. Serra DB, et al. J Clin Pharmacol. 2005;45:1038-1047.6. Haab F, et al. BJU Int. 2006;98:1025-1032.7. Hill S, et al. Curr Med Res Opin. 2007;23:2697-2704.

ENABLEX® Clinical Trial Data: Established Efficacy and Safety



ENABLEX®

as a Treatment Option for Patients With Overactive BladderCase Studies



Amy S.• 52-year-old woman with overactive bladder• Active lifestyle• Overactive bladder treatment-naive

40

Case Study 1

Case studies are illustrative examples and not based on actual patient records.


Amy S.

• 52-year-old, teacher, mother of 4

• Active lifestyle (skis, golfs)

• Tried Kegel exercises

• No other significant medical history

• Meds: statin, NSAIDs

• CC: Strong urge to urinate during the day

• Every 30 minutes

Medical History

41


Amy S. (cont’d)

• No incontinence with coughing, sneezing, laughing, or exercise

unless bladder is full

• Overactive bladder increasingly difficult to control

• Accidents have hindered activities

• No history of previous overactive bladder medication use

• Embarrassed by her overactive bladder symptoms

• Desires a safe and effective treatment

Medical History

42


Assessment

43

Amy S. is a 52-year-old woman with an active lifestyle

•Based on history and symptoms, you agree with the diagnosis of overactive bladder

•You perform a physical exam and order routine tests to rule out other causes


Treatment Plan

44

After considering Amy’s medical history, how would you manage her overactive bladder?




ENABLEX® as an OptionIn clinical studies, ENABLEX® has demonstrated significant reductions in incontinence and urgency episodes

Treatment Plan



ENABLEX® as an OptionIn clinical studies, ENABLEX® has demonstrated significant reductions in incontinence and urgency episodes1

Discontinuation rates from 3 phase 3 studies were minimal1,2

Treatment Plan

1. Chapple C, et al. BJU Int. 2005;95:993-1001.2. Serra DB, et al. J Clin Pharmacol. 2005;45:1038-1047.


Please see Selected Safety Information for ENABLEX® on slide 66 and Full Prescribing Information, which includes the Patient Information, provided by your sales representative and at www.enablex.com.PROPRIETARY AND CONFIDENTIAL - NOT TO BE COPIED, DISTRIBUTED, OR USED IN DETAILING 47

Case Study 2George R.• 69-year-old man•Dissatisfied with current overactive bladder therapy •Considering changing medication for overactive bladder



George R.

• 69-year-old retired businessman

• Overactive bladder diagnosed

6 years ago

• Reluctant to change overactive

bladder medication because the first

one failed

• CC: Despite treatment, patient

complains of strong and frequent

urges to void

48

Medical History


George R. (cont’d)

• Medications • ACE inhibitor

• Oral hypoglycemic

• Concerned that switching treatments may

have potential side effects and not provide

further symptom relief

• Seeks an alternative treatment that is safe,

effective, and can be used longterm

49

Medical History


Assessment

50

George R. is a 69-year-old man requesting treatment for his symptoms


•Perform a physical exam , including prostate exam, and order routine tests, to rule out other causes


Treatment Plan

51

After considering George’s medical history and chief complaint of strong and frequent urges to urinate, how would you manage his overactive bladder?


Treatment Plan

52


ENABLEX® as an OptionAntimuscarinics are currently the treatment of choice in elderly patients with overactive bladder1

1. Chughtai B, et al. Clin Interv Aging. 2008;3:503-509.


Treatment Plan

53



Significant improvements in PPBC scores at week 12 in patients switching from other overactive bladder treatments2

1. Chughtai B, et al. Clin Interv Aging. 2008;3:503-509. 2. Zinner N, et al. Int J Clin Pract. 2008;62:1664-1674.


Treatment Plan

54




High M3 specificity with no significant effect on memory3,4

1. Chughtai B, et al. Clin Interv Aging. 2008;3:503-509. 2. Zinner N, et al. Int J Clin Pract. 2008;62:1664-1674. 3. Lipton RB, et al. J Urol. 2005;173:493-498. 4. Kay G, et al. Eur Urol. 2006;50:317-326.


Treatment Plan

55




High M3 specificity with no significant effect on memory3,4

Consistent efficacy and safety in 12-week pivotal studies and a 2-year extension study5-7

1. Chughtai_B, et al. Clin Interventions Aging. 2008; 3:503-509. 2. Zinner N, et al. Int J Clin Pract. 2008;62:1664-1674. 3. Lipton RB, et al. J Urol. 2005;173:493-498. 4. Kay G, et al. Eur Urol. 2006;50:317-326. 5. Haab F, et al. BJU Int. 2006;98:1025-1032. 6. Hill S, et al. Curr Med Res Opin. 2007;23:2697-2704. 7. Steers W, et al. BJU Int. 2005;95:580-586.


Please see Selected Safety Information for ENABLEX® on slide 66 and Full Prescribing Information, which includes the Patient Information, provided by your sales representative and at www.enablex.com.PROPRIETARY AND CONFIDENTIAL - NOT TO BE COPIED, DISTRIBUTED, OR USED IN DETAILING 56

Case Study 3Joanne J.• 78-year-old woman•Worried about side effects of overactive bladder treatment• History of memory loss



Joanne J.

• 78-year-old retired waitress with dementia

• Lives with daughter

• Overactive bladder for >15 years

• CC: Incontinence limiting her activity

• Concerned that overactive bladder

medications can further compromise her

memory

Medical History


Joanne J. (cont’d)

• Medications: • ACE inhibitor• Cardioselective beta blocker

• Antihyperlipidemic

• Wants to decrease her frequent accidents

and subsequent burden on family

Medical History


Assessment

59

Joanne J. is a 78-year-old woman with history of memory loss who presents with her caretaker (daughter) requesting alternative treatment for her overactive bladder symptoms


•You perform a physical exam and order routine tests, including a urine analysis, to rule out other causes


Treatment Plan

60

After reviewing Joanne’s history and treatment concerns, how would you manage her overactive bladder?


Treatment Plan

61


ENABLEX® as an OptionAs bladder contractions are mediated primarily by

M3 receptors, antimuscarinics with high M3 specificity are ideal for patients with overactive bladder 1

1. Chapple C, et al. BJU Int. 2005;95:993-1001.


Treatment Plan

62


ENABLEX® as an OptionAs bladder contractions are mediated primarily by

M3 receptors, antimuscarinics with high M3 specificity are ideal for patients with overactive bladder1

This is particularly important in elderly patients, who are more vulnerable to potential CNS and other safety concerns2,3

1. Chapple C, et al. BJU Int. 2005;95:993-1001. 2. Kay G, et al. Eur Urol. 2006;50:317-326. 3. Serra DB, et al. J Clin Pharmacol. 2005;45:1038-1047.



ENABLEX® Treatment in a Wide Range of Patients With Overactive Bladder

Summary


1. Chapple C, et al. BJU Int. 2005;95:993-1001. 2. Zinner N, et al. Int J Clin Pract. 2008;62:1664-1674. 3. ENABLEX® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011. 4. Kay G, et al. Eur Urol. 2006;50:317-326. 5. Serra DB, et al. J Clin Pharmacol. 2005;45:1038-1047. 6. Haab F, et al. BJU Int. 2006;98:1025-1032. 7. Hill S, et al. Curr Med Res Opin. 2007;23:2697-2704.

ENABLEX®:Effective Treatment for Overactive Bladder Patients


ENABLEX®:Overactive Bladder Treatment for a Wide Range of Patients

First-line therapy for the active 52-year-old woman• Significant reductions in incontinence and urgency episodes• Minimal discontinuation rates

Treatment for the 69-year-old man who was dissatisfied with previous therapy• Significant improvements in PPBC in patients switching from other overactive

bladder therapies• Consistent efficacy and safety in 12-week pivotal studies and a 2-year

extension study

Therapy for the 78-year-old woman with safety concerns • High M3 selectivity• Low risk of memory deterioration and other AEs

Who is your patient?• •

65


ENABLEX®:Important Safety Information

ENABLEX® (darifenacin) extended-release tablets is contraindicated in patients with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions. ENABLEX® is also contraindicated in patients with known hypersensitivity to the drug or any of its ingredients.

Daily dose should not exceed 7.5 mg when used with potent CYP3A4 inhibitors or in patients with moderate hepatic impairment. ENABLEX® is not recommended for patients with severe hepatic impairment.

ENABLEX® should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention; gastrointestinal obstructive disorders because of the risk of gastric retention; severe constipation, ulcerative colitis, or myasthenia gravis. In patients being treated for narrow-angle glaucoma, ENABLEX® should be used with caution and only where the potential benefits outweigh the risks.

Angioedema of the face, lips, tongue, and/or larynx have been reported with darifenacin, in some cases after the first dose. Angioedema associated with upper airway swelling may be life threatening. Patients should be advised to promptly discontinue darifenacin therapy and seek immediate medical attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing.

In controlled clinical studies the incidence of the most frequently reported adverse events for ENABLEX® 7.5 mg or 15 mg and greater than placebo was: dry mouth (20.2%, 35.3%, 8.2%); constipation (14.8%, 21.3%, 6.2%); dyspepsia (2.7%, 8.4%, 2.6%); abdominal pain (2.4%, 3.9%, 0.5%); nausea (2.7%, 1.5%, 1.5%); diarrhea (2.1%, 0.9%, 1.8%); urinary tract infection (4.7%, 4.5%, 2.6%); dizziness (0.9%, 2.1%, 1.3%); asthenia (1.5%, 2.7%, 1.3%); and dry eyes (1.5%, 2.1%, 0.5%).

Please see full Prescribing Information for ENABLEX® at www.enablex.com.


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