New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

2 nd Annual Essentials in Primary Care
Fall Conference
Friday, November 11, 2011
Buprenorphine Transdermal System - Butrans
• Transdermal buprenorphine was assessed in a study enrolling 1,160
patients with chronic low back pain currently receiving long-term
opioid therapy (morphine 30 to 80 mg equivalent per day). Patients
entered an open-label, dose-titration period with transdermal
buprenorphine for up to 3 weeks following tapering of prior opioids.
Buprenorphine therapy was initiated with the 10 mcg/h dosage for 3
days and then increased to 20 mcg/h for up to 18 days. Patients with
adequate analgesia and tolerable adverse effects at the 20 mcg/h
dosage were randomized to remain on buprenorphine 20 mcg/h or
were switched to low-dosage control (buprenorphine 5 mcg/h) or an
active control (not specified).
– At least a 30% reduction in pain score from screening to end point was achieved
in 49% of patients treated with the 20 mcg/h dosage compared with 33% of
patients treated with the 5 mcg/h dosage
Buprenorphine Transdermal System - Butrans
• 588 patients with persistent non–cancer-related pain
previously treated with oral opioid combination agents
received transdermal buprenorphine during a 7- to 21-
day open-label titration phase; those achieving stable
pain control (267 patients) were randomized to receive
up to 14 days of buprenorphine at the titrated dose or
placebo.
– Treatment was judged ineffective (requiring more than
acetaminophen 1 g as escape medication on any day of the
double-blind phase, requiring a change in study drug or dose,
having difficulty keeping the patch affixed, or discontinuing
treatment because of a lack of efficacy) in 51.2% of
buprenorphine-treated patients compared with 65% of patients
treated with placebo. The odds of ineffective treatment were 1.79
times greater with placebo than with buprenorphine (P = 0.022).
Wayne Weart
New Drug Update Part I