Long-term safety and analgesic efficacy of buprenorphine buccal film in patients with moderate-to-severe chronic pain requiring around-the-clock opioids

Figures & data

Figure 1 Patient disposition.

Table 1 Patient demographics

Characteristics	Titration phase (n=506)	Long-term treatment phase (n=435)
De novo patients, n (%)	61 (12.1)	31 (7.1)
Rollover patients, n (%)	445 (87.9)	404 (92.9)
Age, years (SD)	52.3 (11.8)	52.2 (11.7)
Sex, n (%)
Female	279 (55.1)	240 (55.2)
Male	227 (44.9)	195 (44.8)
Height, cm, mean (SD)	169.8 (10.7)	169.7 (10.7)
Weight,a kg, mean (SD)
At titration phase baseline	92.7 (23.1)	92.0 (22.2)
At long-term treatment phase baseline	92.0 (22.4)	91.9 (22.3)
BMI,a kg/m^2, mean (SD)
At titration phase baseline	32.2 (7.5)	32.0 (7.3)
At long-term treatment phase baseline	32.0 (7.4)	31.9 (7.3)
NRS pain intensity score,b mean (SD)
At titration phase baseline	4.4 (2.2)	4.3 (2.1)
At long-term treatment phase baseline	3.0 (1.3)	3.0 (1.3)
Chronic pain type, n (%)
Low back pain	497 (98.2)	433 (99.5)
Otherc	9 (1.8)	2 (0.5)

Notes: Data are presented as mean (SD) or as n (%).

a Titration phase baseline is defined as the value at the end of the dose taper phase for de novo patients and the value at screening (completion of the double-blind phase in previous studies) for rollover patients.

b NRS scores at titration phase and long-term treatment phase baseline are defined as the values immediately before the start of the relevant phase.

c Other includes chronic hip pain, foot pain, neuropathic pain, and osteoarthritis (each occurring in ≤1% of patients).

Abbreviations: BMI, body mass index; NRS, numerical rating scale; SD, standard deviation.

Table 2 Adverse events occurring in ≥3% of patients in either phase

Adverse events, n (%)	Titration phase (n=506)	Long-term treatment phase (n=435)
Patients with at least 1 adverse event	218 (43.1)	235 (54.0)
Infections and infestations	57 (11.3)	94 (21.6)
Upper respiratory tract infection	10 (2.0)	21 (4.8)
Nasopharyngitis	3 (0.6)	14 (3.2)
Urinary tract infection	11 (2.2)	13 (3.0)
Gastrointestinal disorders	91 (18.0)	77 (17.7)
Nausea	52 (10.3)	36 (8.3)
Vomiting	12 (2.4)	22 (5.1)
Constipation	30 (5.9)	17 (3.9)
Diarrhea	11 (2.2)	15 (3.4)
Nervous system disorders	48 (9.5)	46 (10.6)
Headache	18 (3.6)	19 (4.4)
Musculoskeletal and connective tissue disorders	24 (4.7)	49 (11.3)
Back pain	4 (0.8)	16 (3.7)
Injury, poisoning, and procedural complications	20 (4.0)	49 (11.3)
Falls	6 (1.2)	13 (3.0)

Figure 2 Mean NRS scores during the titration and long-term treatment phases in (A) de novo patients and (B) rollover patients.

Note: The dotted line labeled “phase distinction” indicates the end of the titration phase and the beginning of the long-term treatment phase.
Abbreviation: NRS, numerical rating scale.