Medical Sample 19

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Medical Sample 19

  1. 1. Defining OAB The need to urinate on an abnormally frequent basis (>8 times/day) Frequency – Nocturia defined as need to urinate OAB =2 times/night Comprised Sudden need to urinate which is difficult to defer of urgency, with Urgency or without urge incontinence, Involuntary loss of urine usually with § Urge Leakage accompanied by or frequency and Urinary preceded by urgency § Stress Leakage on effort or exertion; or on nocturia Incontinence sneezing or coughing § Mixed Both urge and stress § Other Situational (i.e. with intercourse or giggle incontinence)
  2. 2. OAB/UI Prevalence Estimates 47 Million Patients 2 million 5 million 26 million 14 million Frequency/Urgency (continent OAB) Urge and Mixed UI (incontinent OAB) Stress UI Other UI UI indicates urinary incontinence.
  3. 3. annotation in annotation in resubmission resubmission OAB Is Prevalent in Men and Women but More Women Are Incontinent Female OAB* Male OAB* Total 20.8 million (16.9%) Total 19.7 million (16.0%) Urge or mixed incontinence Urge or mixed incontinence 55% 14% 11.4 million 2.7 million Urgency/Frequency Urgency/Frequency 45% 86% 9.4 million 17.0 million *Frequency, urgency, urge UI and mixed UI only – does not include stress UI or other UI
  4. 4. OAB Patients Experience Significant Sleep Disturbance* 60 50% 50 48% Patients (%) 40 30 28% 22% 20 10 0 Wake =2x per Night Urinary Symptoms Affect Sleep Incontinence With Stress Incontinence Only (n=386) Urge Component (n=660) *From September 10 to September 16, 2004 women (N=1046) with self-reported symptoms of urinary incontinence completed a nationwide survey via electronic mail about the impact of urinary symptoms, health care provider interactions, treatment practices and expectations, and comorbid conditions.
  5. 5. PCPs Report That Patients Need Rapid, Effective Symptom Relief It is important to identify patients with 91% incontinence and to treat effectively Patients are likely to discontinue medication if they don't reach a 87% threshold of satisfaction Patients expect to see a marked reduction (=50%) in symptoms within 2 72% weeks of starting medication 0 10 20 30 40 50 60 70 80 90 100 PCPs Responding Positively (%)
  6. 6. OAB Market Continues to Grow (+5.25%) 16,000 (+4.7%) (+9.5%) (+3.2%) (+16.4%) 12,000 (+32.1%) TRXs (000s) (+70.6%) 8,000 (+38.4%) 4,000 0 1998 1999 2000 2001 2002 2003 2004 2005
  7. 7. Current Brand OAB Market Chemical Name Recommended Dose Brand Formulation Starting Dosage Frequency Indications 5-10 mg QD – adult • OAB with symptoms of UUI, DITROPAN XL®1 Oxybutynin oral QD 5 mg QD – pediatric urgency, and frequency • Detrusor overactivity in pediatric DITROPAN®2 Oxybutynin oral 5 mg BID to TID BID to TID patients ≥6 years associated with neurologic conditions Detrol LA®3 Tolterodine 4 mg QD QD • OAB with symptoms of UUI, Detrol®4 Tolterodine 2 mg BID BID urgency, and frequency 3.9 mg/day delivery rate • OAB with symptoms of UUI, Oxytrol®5 Oxybutynin patch Twice weekly 39-cm2 patch 2x/wk urgency, and frequency • OAB with symptoms of UUI, Sanctura™6 Trospium 20 mg BID BID urgency, and frequency • OAB with symptoms of UUI, Enablex™7 Darifenacin 7.5 mg QD QD urgency and frequency • OAB with symptoms of UUI, VESIcare®8 Solifenacin 5 mg QD QD urgency and frequency 1. DITROPAN XL® prescribing information. UUI indicates urge urinary incontinence. 2. DITROPAN® prescribing information. 3. Detrol® LA prescribing information. DITROPAN XL and DITROPAN are registered trademarks of ALZA Corporation. 4. Detrol® prescribing information. Detrol is a registered trademark of Pharmacia Corporation. 5. Oxytrol® prescribing information. Oxytrol is a registered trademark of Watson Pharmaceuticals, Inc. 6. Sanctura™ prescribing information. Sanctura is a trademark of Pliva Inc. 7. Enablex™ prescribing information. Enablex is a trademark of Novartis Pharmaceuticals Corporation. 8. VESIcare® prescribing information. VESIcare is a registered trademark of Yamanouchi Pharmaceutical Co.
  8. 8. Rapid Reduction of Urge Urinary Incontinence (UUI) UUI episodes over 12 weeks with DITROPAN XL 10 mg 1,2 80 70 >70% Mean % reduction from 60 Reduction baseline in UUI in wetting 50 >50% episodes episodes at 2 weeks† Reduction 40 in wetting episodes at 2 weeks* 30 20 10 n=559 0 0 2 4 6 8 10 12 Last Observation ‡ Weeks
  9. 9. Pharmacokinetic Profile of DITROPAN XL Is Unaltered With an Antacid DITROPAN XL 1.40 Single dose 10 mg 1.20 Alone Plasma Concentration of With Antacid Oxybutynin (ng/mL) 1.00 0.80 0.60 0.40 P = NS 0.20 0.00 0 4 8 12 16 20 24 28 32 36 Hours Antacid does not alter exposure to DITROPAN XL
  10. 10. OROS Delivery System Allows DITROPAN XL to Provide More Consistent Therapeutic Drug Levels Semipermeable Membrane Color Overcoat Delivery Orifice Drug Core Osmotically Active Polymeric Push Compartment
  11. 11. DITROPAN XL Minimizes Peaks and Troughs Associated With Oxybutynin Oxybutynin Plasma Concentrations Day 4 Steady State 15 IR Oxybutynin, 15 mg/d (5 mg q8 h) Concentration (ng/mL) DITROPAN XL, 15 mg/d (15 mg q24 h) Plasma Oxybutynin 12 9 6 3 0 0 6 12 18 24 Time (h)

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