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Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.
Significant Decrease in Urinary Incontinence in Both Pivotal Studies
Study 515Week 2
Week 6
Week 12
-25
-20
-15
-10
-5
0
PlaceboN=149200UN=135
Mea
n ch
ange
from
bas
elin
e (e
piso
des/
wee
k)
Study 516Week 2
Week 6
Week 12
-25
-20
-15
-10
-5
0PlaceboN=92200UN=92
Mea
n ch
ange
from
bas
elin
e (e
piso
des/
wee
k)
*
** **
* p= <0.05; ** p= <0.001 in pairwise comparison versus placebo
Mean baselines:Placebo = 28.3/wk, 200U = 32.3/wk
**
**
Mean baselines:Placebo = 36.7/wk, 200U = 32.5/wk
1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial
Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.
High Proportion of Treatment Responders
% of patients with ≥50% decrease in urinary
incontinence
Placebo 200U0
10
20
30
40
50
60
70
80
90
100
Week 6
% o
f P
ati
en
ts% of patients with 100%
decrease in urinary incontinence (‘DRY’)
Placebo 200U0
10
20
30
40
50
60
70
80
90
100
% o
f P
ati
en
ts
**
** p= <0.001 in among-group comparison,
**
Week 6
1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial
Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.
Significant Increase in MCC in Both Pivotal Studies
Study 515
Series10
20
40
60
80
100
120
140
160
180
PlaceboN=129
200UN=123
Mea
n ch
ange
from
bas
elin
e (m
L)
Study 516
Series10
20
40
60
80
100
120
140
160
180
PlaceboN=85
200UN=88
** **
** p= <0.001 in pairwise comparison versus placebo
1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial
Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.
Series1
-40
-35
-30
-25
-20
-15
-10
-5
0
5
10
PlaceboN=68
200UN=29
Mea
n ch
ange
from
bas
elin
e (c
mH2
O)
Significant Reduction in MDP During First IDC in Both Pivotal Studies
Study 515
Series1
-40
-35
-30
-25
-20
-15
-10
-5
0
5
10
PlaceboN=103
200UN=41
Mea
n ch
ange
from
bas
elin
e (c
mH
2O)
Study 516
**
**
** p= <0.001 in pairwise comparison versus placebo
1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial
Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.
Week 6
Week 12
0
5
10
15
20
25
30
35
PlaceboN=149
200UN=135
Mea
n ch
ange
from
bas
elin
e (t
otal
sco
re)
Week 6
Week 12
0
5
10
15
20
25
30
PlaceboN=92
200UN=92
Mea
n ch
ange
from
bas
elin
e (t
otal
sco
re)
Significant Improvement in Quality of Life in Both Pivotal Studies
** p= <0.001 in pairwise comparison versus placebo
Study 515 Study 516
Baseline Baseline
1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial
Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.
Placebo
200U
0 10 20 30 40 50
Weeks
Long Duration of Effect:Patient Request for Re-Treatment
Patient could not request re-treatment until week 12
Median = 38.4 weeks
Median = 13.1 weeks
1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial