NOW for the treatment of overactive bladder
Keep the power...
Calm the symptoms. Continue the delivery.
Get inside...
The Comfort Zone for calm continuous relief
The most commonly reported adverse events were application site reactions, dry mouth, constipation, diarrhea, dysuria, and abnormal vision. Please see full prescribing information.
Calm. Continuous. Relief.
EFFICACY
elieve symptoms R with powerful efficacy
OXYTROL™ achieved a 75% reduction in incontinence episodes in Study 21 Reduction (%) in daily incontinence episodes in second phase 3 study1§ Median number of daily episodes
61% and 75% reduction in incontinence episodes1
Median number of weekly episodes
In Study 1, OXYTROL™ achieved a 61% reduction in incontinence episodes1 Reduction (%) in weekly incontinence episodes in first phase 3 study1* 40 30
4
3
75%
4
reduction P=.0137†
2
2
1 0
1 Baseline
Week 12 Study 2 (n=121)ll OXYTROL™ 3.9 mg/day
Baseline
Week 12 Study 2 (n=117)ll Placebo
61% 31
reduction P=.0265†
30
• 39% of OXYTROL™ patients reported no incontinence episodes at study end point 2
20 10 0
4
12 Baseline
Week 12 ‡
Study 1 (n=120) OXYTROL™ 3.9 mg/day
• 100% of patients had received a beneficial response from prior anticholinergic therapy at time of study entry1
15 Baseline
New OXYTROL™—Proven efficacy of oxybutynin delivered in a whole new way
Week 12
Study 1 (n=127)‡ Placebo
Transdermal OXYTROL™ 3.9 mg/day is indicated for the treatment of overactive bladder with symptoms of 1 —Urge urinary incontinence —Urgency —Frequency
• 15% of OXYTROL™ patients reported no incontinence episodes at study end point2 • Only 22% of patients had received prior anticholinergic therapy at study entry3
2 2% of patients in the placebo group reported no incontinence episodes at study end point.2 ll Median change from baseline to end of treatment in a second 12-week, multicenter, randomized study of OXYTROL™ 3.9 mg/day (n=121); placebo (n=117) vs active and placebo controls. All patients had prior beneficial responses to pharmacologic treatment of overactive bladder. §
*8.6% of patients in the placebo group reported no incontinence episodes at study end point. † Comparison significant if P<.05. ‡ Median change from baseline to end of treatment: OXYTROL™ 3.9 mg/day (n=120); placebo (n=127). Study was a phase 3, 12-week, randomized, double-blind, placebo-controlled trial of OXYTROL™ (1.3, 2.6, and 3.9 mg/day) vs placebo. Throughout the study, patients were instructed to continue nonpharmacologic treatment measures; eg, pelvic floor exercise, timed voiding, or other behavioral techniques consistent with standard practices. 2
Please see full prescribing information.
Calm. Continuous. Relief.
A favorable safety profile • Dry mouth, constipation, and dizziness were not significantly different than placebo1,2*
No serious treatment-related adverse events reported with OXYTROL™1
SAFETY
Low incidence of anticholinergic adverse events1,2
†
• 49% of patients enrolled in clinical safety studies were ≥65 years of age1 —19% were ≥75 years of age2
Adverse events occurring in 2% of OXYTROL™–treated patients and greater in OXYTROL™ group than in placebo group1†
Study 1‡ Placebo OXYTROL™ Pruritus Dry mouth Erythemall Constipation Rashll Diarrhea Vesiclesll Abnormal vision Maculesll Dysuria ll
(n=132)
(n=125)
6.1% 8.3% 2.3% — — 2.3% 0.0% — — 0.0%
16.8% 9.6% 5.6% — — 3.2% 3.2% — — 2.4%
Study 2 § Placebo OXYTROL™ (n=117)
(n=121)
4.3% 1.7% 1.7% 0.0% 0.9% — — 0.0% 0.0% —
14.0% 4.1% 8.3% 3.3% 3.3% — — 2.5% 2.5% —
• Most treatment-related adverse events were mild or moderate in intensity. Severe application site reactions were reported by 6.4% and 5.0% of OXYTROL™-treated patients in studies 1 and 2, respectively1
*Comparison significant if P<.05. † The safety of OXYTROL™ was evaluated in a total of 417 patients from 2 clinical efficacy and safety studies and an open-label extension. Includes all patients receiving OXYTROL™ 3.9 mg/day. ‡ 78% of patients in Study 1 had no prior pharmacologic treatment for overactive bladder. § 100% of patients in Study 2 had a prior beneficial response to pharmacologic treatment for overactive bladder. ll These adverse events were localized to application site.
Please see full prescribing information.
• Overall, approximately 11% of patients discontinued treatment due to adverse events1 — Most were secondary to application site reactions —No patients discontinued due to dry mouth
Up to 92% of patients chose to continue to the open-label extension study of OXYTROL™3¶ OXYTROL™ is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. OXYTROL™ is also contraindicated in patients who have demonstrated hypersensitivity to oxybutynin or other components of the product. OXYTROL™ should be administered with caution in the following patients: those with hepatic or renal impairment; clinically significant bladder outflow obstruction; gastrointestinal obstructive disorders because of the risk of gastric retention; patients with gastroesophageal reflux.
Proportion of patients continuing to open-label extensions of the 2 studies. Following week 12 of the studies, all eligible patients were allowed to continue treatment for an additional 12 weeks in open-label extensions.
¶
Calm. Continuous. Relief.
A unique pharmacokinetic profile
• Transdermal oxybutynin is passively diffused into the systemic circulation1
— Achieves therapeutic plasma concentrations at less than half the daily dose of oral immediaterelease oxybutynin4
Parent drug (oxybutynin) and metabolite (N-DEO) concentrations: OXYTROL™ vs immediate-release oxybutynin1,3* 25 Parent drug (oxybutynin)
20
19.8
Metabolite (N-DEO)
PHARMACOKINETICS
• OXYTROL™ 3.9 mg/day delivers more parent drug with less metabolite1,2
OXYTROL™ provides 80% lower metabolite concentrations than oral immediate-release oxybutynin1
Plasma concentration (ng/mL)
Transdermal delivery bypasses first-pass gastric and hepatic metabolism1
15
10
5
0
2.5
3.9 OXYTROL™
1.8 Immediate Release
* Average plasma concentrations measured after a single 96-hour application of OXYTROL™ 3.9 mg/day and a single 5 mg oral immediate-release dose of oxybutynin in 16 healthy volunteers.
Please see full prescribing information.
Calm. Continuous. Relief.
Long lasting and consistent delivery OXYTROL™ provides ALL-DAY and ALL-NIGHT delivery of oxybutynin for 4 DAYS (up to 96 hours)1 • Allows for convenient twice-weekly dosing
1
Unique matrix transdermal technology ✓ Thin ✓ Flexible
• Steady-state plasma concentrations achieved within 1 week1
✓ Virtually transparent
• Plasma concentrations decline within 1 to 2 hours following complete removal of patch1
The OXYTROL™ transdermal system • Each 39 cm2 system contains 36 mg of oxybutynin for
Steady-state plasma concentrations of oxybutynin following application of OXYTROL™ 3.9 mg/day1*
nominal delivery of 3.9 mg/day1
4
3
Placebo Patch Goes Here
2
Not for patient use. This system is for demonstration purposes only and contains no active ingredients.
1
0
0
12
24
36
48
60
72
84
96
Hours (post second application) Day 1
Day 2
Day 3
Day 4
*Plasma oxybutynin concentrations measured during a multiple-dose, randomized, crossover study in 13 healthy volunteers.
Please see full prescribing information.
Calm. Continuous. Relief.
TRANSDERMAL SYSTEM
Plasma concentration (ng/mL)
5
Relief with convenience OXYTROL™—Easy to wear
Easy to dose
• Consistent adhesion observed in more than 4700 evaluations1*†
• Choose any 2-day combination for convenient twice-weekly dosing
— System falloff was observed in 0.4% of evaluations
• Remind patients to change their patch on the same 2 days each week
— Partial detachment was observed in 0.7% of evaluations
❍ ❍ ❍ ❍ ❍ ❍ ❍
• Bathing, swimming, and exercise should not affect adhesion5 • Apply OXYTROL™ to dry, intact skin on the abdomen, hip, or buttock— absorption is equivalent1 —Choose a new site with each application —Avoid reapplication to the same site within 7 days
abdomen
hip
Sunday/Wednesday Monday/Thursday Tuesday/Friday Wednesday/Saturday Thursday/Sunday Friday/Monday Saturday/Tuesday
buttock
The most common application site adverse events were pruritus and erythema.
Easy to write • 1-month supply (8 patches per box)
Oxytrol #8
TM
Sig: Apply 1 patch twice weekly as directed Refills x 5
DOSING
* In 2 clinical studies, consistent adhesion was defined as ≥75% of the surface of the transdermal system being in contact with the patient’s skin as evaluated during a clinic visit. † Patients who participated in the studies were not bound by any restrictions in activity.
Please see full prescribing information.
Calm. Continuous. Relief.
NOW for the treatment of overactive bladder
Get inside…
The Comfort Zone
for calm continuous relief
Keep the power • Oxybutynin delivered through unique transdermal technology — Bypasses first-pass metabolism to provide more drug with less metabolite1 • Provides ALL-DAY, ALL-NIGHT delivery for up to 4 days1 —Allows for convenient twice-weekly dosing
Calm the symptoms • 61% and 75% reduction in incontinence episodes in 2 major clinical trials1
A favorable safety profile • Low incidence of anticholinergic side effects1,2 — Dry mouth, constipation, and dizziness not significantly different than placebo1,2* • No patients discontinued due to dry mouth1
Oxytrol #8
TM
Sig: Apply 1 patch twice weekly as directed
The most commonly reported adverse events were application site reactions, Refills x 5 dry mouth, constipation, diarrhea, dysuria, and abnormal vision. OXYTROL™ is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. OXYTROL™ is also contraindicated in patients who have demonstrated hypersensitivity to oxybutynin or other components of the product. OXYTROL™ should be administered with caution in the following patients: those with hepatic or renal impairment; clinically significant bladder outflow obstruction; gastrointestinal obstructive disorders because of the risk of gastric retention; patients with gastroesophageal reflux. *Comparison significant if P<.05. References: 1. OXYTROL™ Prescribing Information. 2. Data on file, Watson Pharma, Inc. 3. Dmochowski RR, Davila GW, Zinner NR, et al, for the Transdermal Oxybutynin Study Group. Efficacy and safety of transdermal oxybutynin in patients with urge and mixed urinary incontinence. J Urol. 2002;168:580-586. 4. Zobrist RH, Schmid B, Feick A, Quan D, Sanders SW. Pharmacokinetics of the R- and S-enantiomers of oxybutynin and N-desethyloxybutynin following oral and transdermal administration of the racemate in healthy volunteers. Pharm Res. 2001;18:1029-1034. 5. OXYTROL™ Patient Prescribing Information.
Please see full prescribing information.
Calm. Continuous. Relief.