TY - JOUR
KW - Administration, Sublingual
KW - Adult
KW - Analgesics, Opioid/administration & dosage/therapeutic use
KW - Buprenorphine, Naloxone Drug Combination/administration & dosage/therapeutic use
KW - Drug Administration Schedule
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Male
KW - Middle Aged
KW - Narcotic Antagonists/administration & dosage/therapeutic use
KW - Opiate Substitution Treatment/methods
KW - Opioid-Related Disorders/drug therapy
KW - Treatment Outcome
AU - K. Hoffman
AU - M. L. Peyton
AU - M. Sumner
A1 - 
AB - OBJECTIVE: To assess the safety of rapidly dissolving buprenorphine/naloxone sublingual tablets (BNX-RDT) in opioid-dependent patients. METHODS: This open-label, 24-week extension study enrolled patients who completed primary trials of BNX-RDT. Daily tablet doses ranged from 5.7 to 17.1 mg. The primary endpoint was safety; secondary assessments included opioid cravings, addiction severity, health-related quality of life (QOL), and workplace productivity at screening (final day of the primary trials) through study end, with changes measured from baseline of the primary trials. RESULTS: In all, 665 patients received treatment; 292 (43.9%) completed the study. A total of 258 patients (38.8%) reported 557 treatment-emergent adverse events, most commonly headache (3.2%) and constipation (3.0%). Craving scores showed continued improvement on 100-mm visual analog scale (mean change from primary trial baseline, -52.8 at screening; mean change from extension trial baseline, -60.5 at week 24). Reductions in addiction severity from baseline of both the primary and extension trial were maintained through week 24 on multiple assessments, as were improvements in QOL on Short Form 36. Employment increased by 15% and mean (SD) hours worked per week increased by 4.6 (20.1) from baseline to study end. Mean (SD) scores for impact of opioid dependence on work productivity improved from 4.7 (3.0) at baseline to 0.9 (1.8) at study end (11-point scale). CONCLUSIONS: Extended treatment with BNX-RDT demonstrated a safety profile similar to other BNX formulations, reduced opioid cravings, and improved both QOL and work productivity. Continued treatment may enable patients to advance in recovery and return to normal functioning.
AD - Lake Howell Health Center, Maitland, FL (KH); Oklahoma Clinical Research, Oklahoma City, OK (MLP); and Orexo US, Inc., Morristown, NJ (MS).
BT - Journal of addiction medicine
C5 - Opioids & Substance Use
CP - 3
CY - United States
DO - 10.1097/ADM.0000000000000301
IS - 3
JF - Journal of addiction medicine
M1 - Journal Article
N2 - OBJECTIVE: To assess the safety of rapidly dissolving buprenorphine/naloxone sublingual tablets (BNX-RDT) in opioid-dependent patients. METHODS: This open-label, 24-week extension study enrolled patients who completed primary trials of BNX-RDT. Daily tablet doses ranged from 5.7 to 17.1 mg. The primary endpoint was safety; secondary assessments included opioid cravings, addiction severity, health-related quality of life (QOL), and workplace productivity at screening (final day of the primary trials) through study end, with changes measured from baseline of the primary trials. RESULTS: In all, 665 patients received treatment; 292 (43.9%) completed the study. A total of 258 patients (38.8%) reported 557 treatment-emergent adverse events, most commonly headache (3.2%) and constipation (3.0%). Craving scores showed continued improvement on 100-mm visual analog scale (mean change from primary trial baseline, -52.8 at screening; mean change from extension trial baseline, -60.5 at week 24). Reductions in addiction severity from baseline of both the primary and extension trial were maintained through week 24 on multiple assessments, as were improvements in QOL on Short Form 36. Employment increased by 15% and mean (SD) hours worked per week increased by 4.6 (20.1) from baseline to study end. Mean (SD) scores for impact of opioid dependence on work productivity improved from 4.7 (3.0) at baseline to 0.9 (1.8) at study end (11-point scale). CONCLUSIONS: Extended treatment with BNX-RDT demonstrated a safety profile similar to other BNX formulations, reduced opioid cravings, and improved both QOL and work productivity. Continued treatment may enable patients to advance in recovery and return to normal functioning.
PP - United States
PY - 2017
SN - 1935-3227; 1932-0620
SP - 217
EP - 223
EP - 
T1 - Safety of a Rapidly Dissolving Buprenorphine/Naloxone Sublingual Tablet (BNX-RDT) for Treatment of Opioid Dependence: A Multicenter, Open-label Extension Study
T2 - Journal of addiction medicine
TI - Safety of a Rapidly Dissolving Buprenorphine/Naloxone Sublingual Tablet (BNX-RDT) for Treatment of Opioid Dependence: A Multicenter, Open-label Extension Study
U1 - Opioids & Substance Use
U2 - 28353467
U3 - 10.1097/ADM.0000000000000301
VL - 11
VO - 1935-3227; 1932-0620
Y1 - 2017
Y2 - May/Jun
ER -