Fentanyl Sublingual Spray for Breakthrough Cancer Pain in Patients Receiving Transdermal Fentanyl

Figures & data

Figure 1. Baseline titration and double-blind Treatment Satisfaction Questionnaire for Medication scores for the around-the-clock transdermal fentanyl patch subgroup (intent-to-treat population).

^†Side effects, convenience and global satisfaction data not available for one double-blind period patient.

TSQM: Treatment Satisfaction Questionnaire for Medication.

Table 1. Demographics and baseline characteristics of patients receiving around-the-clock transdermal fentanyl patch (titration and intent-to-treat populations).

Characteristic	Patients receiving ATC transdermal fentanyl patch
	Titration population (n = 50)	ITT population (n = 32)
Age (years):
– Mean (SD)	58.5 (13.2)	58.1 (12.7)
– Range	24.0–85.0	24.0–85.0
Male sex, n (%)	29 (58.0)	18 (56.2)
Race, n (%):
– White	45 (90.0)	29 (90.6)
– Black	4 (8.0)	3 (9.4)
– Other	1 (2.0)	0
Ethnicity, n (%):
– Hispanic/Latino	2 (4.0)	1 (3.1)
– Non-Hispanic/Latino	48 (96.0)	31 (96.9)
Most common types of cancer, n (%):
– Reproductive	11 (22.0)	6 (18.8)
– Head/neck	7 (14.0)	3 (9.4)
– Lung	4 (8.0)	4 (12.5)
– Colon/colorectal	4 (8.0)	4 (12.5)
– Esophageal	3 (6.0)	3 (9.4)
– Other	21 (42.0)	12 (37.5)
Stage of cancer, n (%):
– 0	2 (4.0)	2 (6.3)
– I	5 (10.0)	2 (6.3)
–II	5 (10.0)	3 (9.4)
– III	11 (22.0)	8 (25.0)
– IV	13 (26.0)	9 (28.1)
– Unknown/missing	14 (28.0)	8 (25.0)
BTCP episodes, mean (SD); n	2.4 (2.1)	2.3 (1.1)
ATC fentanyl dose:
– Mean (SD); µg	82.9 (55.8)	81.4 (52.4)
– Median (range); µg	75.0 (7.5–250.0)	75.0 (25.0–200.0)

ATC: Around-the-clock; BTCP: Breakthrough cancer pain; ITT: Intent-to-treat; SD: Standard deviation.

Table 2. Distribution of final transdermal fentanyl doses in relation to mean effective fentanyl sublingual spray doses.

Final transdermal fentanyl dose, titration (µg/h)	Mean effective fentanyl sublingual spray dose, double-blind (µg)	Patients (n)
<50	550	8
50 to <100	1000	11
100 to <150	933	9
150 to <200	800	1
200 to <250	1400	2
≥250	1200	1

Table 3. Adverse events^† during open-label titration period (titration population) and double-blind period (intent-to-treat population).

Adverse event	Open-label titration period, n (%)		Double-blind period, n (%)
	Fentanyl transdermal patch (n = 50)	Other ATC medications (n = 80)	Fentanyl transdermal patch (n = 32)	Other ATC medications (n = 64)
Peripheral edema	6 (12.0)	2 (2.5)	3 (9.4)	2 (3.1)
Nausea	5 (10.0)	9 (11.3)	3 (9.4)	5 (7.8)
Dizziness	4 (8.0)	0	2 (6.3)	0
Pyrexia	4 (8.0)	1 (1.3)	1 (3.1)	0
Somnolence	4 (8.0)	2 (2.5)	1 (3.1)	1 (1.6)
Anemia	3 (6.0)	0	2 (6.3)	0
Confusional state	3 (6.0)	0	0	0
Cough	3 (6.0)	1 (1.3)	2 (6.3)	1 (1.6)
Hyperhidrosis	3 (6.0)	3 (3.8)	2 (6.3)	3 (4.7)
Urinary tract infection	3 (6.0)	2 (2.5)	1 (3.1)	2 (3.1)
Vomiting	3 (6.0)	4 (5.0)	2 (6.3)	2 (3.1)
Flushing	2 (4.0)	0	2 (6.3)	0
Headache	0	4 (5.0)	0	2 (3.1)

^†Reported in ≥5% of patients in either treatment group during either period. Ordered by frequency in open-label titration period, fentanyl transdermal patch group.

ATC: Around-the-clock.