Management of moderate to severe chronic low back pain with buprenorphine buccal film using novel bioerodible mucoadhesive technology

Figures & data

Figure 1 A literature search was conducted using PubMed, Cochrane, Embase, and Scopus databases, resulting in nine articles relevant to the objective.

Table 1 Pharmacokinetic parameters across various buprenorphine products indicated for pain control

	Cmax (ng/mL)	AUC0–t (h ng/mL)	AUC0–inf (h ng/mL)	Tmax (hours), median (range)	Absolute bioavailability (%)
Transdermal 7 d/5 µg/h	0.176	–	12.087	26	15
Transdermal 7 d/10 µg/h	0.191	27.543	27.035	26	15
Transdermal 7 d/20 µg/h	0.471	–	54.294	26	15
BBUP (Belbuca) 75 µg	0.17±0.30	0.46±0.22	0.63±0.24	3.0 (1.5–4.0)	46–65
BBUP (Belbuca) 300 µg	0.47±0.47	2.00±0.68	2.3±0.68	2.5 (0.5–4.0)	46–65
BBUP (Belbuca) 1,200 µg	1.43±0.45	9.6±2.9	10.5±3.32	3.0 (1.0–4.0)	46–65

Note: “–” data not available. Data from Endo⁴⁹ and Purdue Pharma⁵¹ package inserts.

Abbreviation: BBUP, buccal buprenorphine.

Figure 2 Significantly more patients achieved ≥30% pain reduction in the BBUP (63%) vs placebo (47%) groups, P=0.0012.

Note: Significance is indicated by the asterisk. The black bars indicate the proportion of patients who achieved at ≥30% and ≥50% pain intensity with BBUP. The white bars indicate the placebo rates. Data from Rauck et al.⁵²
Abbreviation: BBUP, buccal buprenorphine.

Endo [webpage on the Internet]BELBUCA-Buprenorphine Hydrochloride FilmHighlights of Prescribing Information2015 Available from: http://www.endo.com/File%20Library/Products/Prescribing%20Information/BELBUCA_prescribing_information.htmlAccessed June 9, 2016

 Google Scholar

Purdue Pharma [webpage on the Internet]BUTRANS-Buprenorphine Patch, Extended Release2014 Available from: http://app.purduepharma.com/xmlpublishing/pi.aspx?id=bAccessed June 9, 2016

 Google Scholar

RauckRLPottsJXiangQTzanisEFinnAEfficacy and tolerability of buccal buprenorphine in opioid-naive patients with moderate to severe chronic low back painPostgrad Med20161281111

 PubMed Web of Science ®Google Scholar