Buprenorphine is a schedule III controlled substance with partial agonist activity at the μ-opioid receptor and competitive antagonist activity at the kappa opioid receptor. The patch represents a new formulation for the opioid, which previously was available as an intramuscular/intravenous injection (Buprenex; Reckitt Benkiser Pharmaceuticals, Inc) for the relief of moderate to severe pain.
"Healthcare professionals now have an important new option for appropriate adult patients suffering from moderate to severe chronic pain when an opioid may be needed to manage their pain," said Lynn R. Webster, MD, FACPM, FASAM, medical director of the Lifetree Clinical Research and Pain Clinic in Salt Lake City, Utah, in a company news release.
Buprenorphine patches should only be used in patients requiring continuous opioid therapy for an extended time; use is contraindicated in the management of acute or short-term pain, postoperative pain, mild pain, and intermittent pain.
Clinical Study Findings
FDA approval of the product was based on data from 2 randomized, double-blind, clinical studies of patients with moderate to severe chronic lower back pain who underwent an open-label dose-titration phase before randomization to a 12-week study period.
Results showed that the mean pain score during the last 24 hours at the end of the study (week 12/early termination) was significantly lower for patients on the buprenorphine patch relative to placebo, as evaluated on an 11-point, 0 to 10 numerical rating scale. Of 256 patients receiving buprenorphine, 9% discontinued use because of lack of efficacy, and 16% discontinued use because of adverse events (vs placebo, 13% and 7%, respectively).
In the second study, 57% of 1160 opioid-tolerant enrollees were able to titrate to, and tolerate, a 20 μg/hour buprenorphine patch during the open-label phase after taper of prior opioids; 12% of patients discontinued use because of adverse events, and 21% discontinued use because of lack of therapeutic effect. The remaining patients were randomly assigned to receive either continued treatment with the 20 μg/hour patch or a low, 5 μg/hour, dose.
Results showed that the 20 μg/hour buprenorphine patch yielded a significant decrease in mean pain score relative to the 5 μg/hour patch, and a higher proportion of those receiving 20 μg/hour buprenorphine achieved a 30% or greater reduction in pain score from baseline (49% vs 33%). During the treatment phase, 11% of patients receiving 20 μg/hour buprenorphine discontinued use because of lack of efficacy and 13% discontinued use because of adverse events (vs 5 μg/hour dose, 24% and 6%, respectively).
Two additional studies were conducted of the buprenorphine patch: one low back pain study failed to show efficacy, and an osteoarthritis study failed to show efficacy for both the patch and the active comparator.
The most commonly reported treatment-related adverse events (incidence ≥ 5%) included nausea, headache, application-site pruritus, dizziness, constipation, somnolence, vomiting, application-site erythema, dry mouth, and application-site rash. Rare cases of severe application-site reactions with signs of marked inflammation, including burn, discharge, and vesicles, have occurred within days to months of treatment initiation.
Administration of Drug
Buprenorphine patches should be applied on a rotating basis to sites on the outer arm, upper chest, upper back, or side of chest once every 7 days. Because of the risk for QTc interval prolongation, the dose should not exceed a single 20 μg/hour patch. Patch exposure to direct heat sources should be avoided because temperature-dependent increases in buprenorphine exposure can lead to overdose and death.
For opioid-naive patients and those with mild to moderate hepatic impairment, buprenorphine therapy should be initiated with a 5 μg/hour patch.
When converting opioid-tolerant patients to buprenorphine patches, current around-the-clock therapy should be tapered for up to 7 days to no more than 30 mg oral morphine or equivalent daily. Patients originally requiring less than 30 mg oral morphine equivalents daily should start buprenorphine therapy with a 5 μg/hour patch; those requiring between 30 and 80 mg oral morphine equivalents daily should start with a 10 μg/hour patch.
Up-titration may be instituted at a minimum interval of 72 hours; the 20 μg/hour patch may not provide adequate analgesia for patients requiring more than 80 mg/day oral morphine equivalents.
?FDA Approves 7-Day Buprenorphine Pain PatchOriginally from: http://www.nursinglink.monster.com/news/articles/15051-fda-approves-7-day-buprenorphine-pain-patch
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