BELBUCA

AbsorptionSystemic plasma levels of buprenorphine increased in a linear manner (C max and AUC) over the single dose range of 75 to 1200 mcg as shown in Table 7. The absolute bioavailability of BELBUCA ranged from 46 to 65%.

Table 7Mean (± SD) BELBUCA Pharmacokinetic Parameters Regimen Dosage (mcg) C max (ng/mL) AUC 0-t (h∙ng/mL) AUC 0-∞ (h∙ng/mL) T max T max values reported as median and range (hr) Single Dose 75 0.17±0.30 0.46±0.22 0.63±0.24 3.00 (1.50-4.00) 300 0.47±0.47 2.00±0.68 2.3±0.68 ...

The efficacy of BELBUCA has been evaluated in three 12-week double-blind, placebo-controlled clinical trials in patients who were not opioid tolerant and opioid-experienced patients with moderate-to-severe chronic low back pain using pain scores as the primary efficacy variable. Two of these studies, described below, demonstrated efficacy in patients with low back pain. One study in low back pain did not show a statistically significant pain reduction for BELBUCA compared to placebo. 12-Week Study in Patients who were not Opioid Tolerant with Chronic Low Back Pain A total of 749 patients with ...

The following serious adverse reactions described elsewhere in the labeling include: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.6) ] Adrenal Insufficie...

BELBUCA is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.7) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12) ] Hypersensitivity (e.g., an...

Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation. ( 5.6 ). Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Regularly evaluate, particularly durin...

7 DRUG INTERACTIONS Table 5 includes clinically significant drug interactions with BELBUCA.

Table 5Clinically Significant Drug Interactions Benzodiazepines Clinical Impact: There have been a number of reports regarding coma and death associated with the misuse and abuse of the combination of buprenorphine and benzodiazepines. In many, but not all of these cases, buprenorphine was misused by self...