Table 8

Efficacy endpoints in randomised controlled studies

FormulationsPrimaryPIDPIDPIPR GMP/GPReference
1530456015
>33%
decrease
30 min
OTFC
Nasal spray
Time to pain relief1.73.4
4.2
p<0.001
4.6
4.4
p<0.01
22%
54%
p<0.001
59
FPNS
Nasal spray
>33% PID60
SLF
Placebo
SPID 30 min2.2
1.4
1.8
1.2
p=0.0002
3.1 (PGEM score)
3.6
61
SLF
Placebo
PID 30 min22
21
NS
VAS mm
41
34
p=0.002
VAS mm
56
45
p<0.001
VAS mm
62
SLF
IRMS oral
PI3 days: 6.0 (SLF) vs 6.9 (M)
30 days: 3.0 (SLF) vs 4.4 (M)
p<0.001
63
SLF-E
Placebo
SPID 30 min2.3
1.6
p<0.0001
64
OTFC
IRMS oral
PID 15 min1.8
1.4
p<0.01
2.8
2.3
p<0.01
3.4
2.9
p<0.01
3.9
3.3
p<0.01
42%
32%
p<0.001
O<M
p<0.05
(no data)
1.8
1.5
p<0.01
 2.5
2.1
p<0.001
65
OTFC
Mor IV
2.8
3.6
p=0.013
4.5
5.2
NS
57%
74%
−41%
−52%
p=0.026
66
OTFC
Placebo
SPID1.45
0.98
p<0.0001
1.85
1.19
p<0.0001
2.15
1.64
p<0.0001
2.28
1.67
p<0.0001
1.85
1.19
1.98 (30 min)
1.19
p<0.0001
67
Buccal
Placebo
SPID 30 min0.8
0.5
p<0.0003
2.2
1.3
p<0.0001
3.3
1.8
p<0.0001
3.8
2.1
p<0.0001
48%
29%
p<0.0001
1.3
0.8
p<0.0001
1.4 (30 min)
0.9
p<0.0001
68
Buccal
Placebo
SPID 60 min1.4
0.8
p<0.0001
2.3
1.2
p<0.0001
2.8
1.4
p<0.0001
3.2
1.5
p<0.0001
51%
26%
p<0.0001
1.7
1.1
p<0.0001
2.1 (60 min)
1.2
p<0.0001
69
Buccal
Placebo
PID 30 min1.2
1.0
NS
2.3
1.8
p<0.05


3.3
2.4
p<0.05
60%
42%
p<0.05 (60 min)
2.0
1.5
70
Buccal film
Placebo
SPID 30 min1.4
1.2
NS
2.3
1.8
p<0.05
2.8
2.2
p<0.01
3.2
2.3
p<0.001
26%
21%
NS
71
Nasal spray
Placebo
PID 10 min2.5
1.3
10 min
p<0.001
4.2
2.1
40 min
p<0.001
4.3
2.3
p<0.001
80%
45%
p<0.001
1.9
1.0
p<0.001
72
FPNS
IRMS oral
PID 15 min3.0
2.7
p<0.05
4.1
3.8
p<0.05
4.7
4.2
p<0.05
5.3
4.8
p<0.01
75%
69%
(PID >2) at 15 min
p<0.05
73
FPNS
IRMS oral
No. of patients with benefit at 15 and 30 min72%
59%
p<0.0005
74
FPNS
Placebo
SPID 30 min2.0
1.3
p<0.001
2.7
1.9
p<0.001
3.1
1.9
p<0.001
3.4
2.0
p<0.001
66%
40%
(PID >2)
75
  • FPNS, fentanyl pectin nasal spray; GMP, global medication performance; GP, global performance; IRMS, immediate release morphine sulfate; IV, intravenous; Mor, morphine; Nasal, fentanyl nasal spray; O<M, OTFC lower pain intensity versus IRMS; OTFC, oral transmucosal fentanyl citrate; PGEM score, patients' global evaluation of medication; PI, pain intensity; PID, pain intensity difference; PR, pain relief; SLF, sublingual fentanyl (Abstral); SLF-E, sublingual fentanyl ethypharm (Recivit); SPID, sum of pain intensity differences; VAS, Visual Analogue Scale.