Seven-day, transdermal buprenorphine patches are as effective as sublingual buprenorphine in the treatment of patients with osteoarthritis pain, according to a randomized, double-blind clinical trial recently published on-line ahead of print in the Journal of Pain and Symptom Management.
Seven-day, transdermal buprenorphine patches are as effective as sublingual buprenorphine in the treatment of patients with osteoarthritis pain, according to a randomized, double-blind clinical trial recently published on-line ahead of print in the Journal of Pain and Symptom Management.
In this clinical trial, researchers randomized 246 patients (110 completed the study) between the ages of 18 and 80 with osteoarthritis pain in either the hip(s) and/or knee(s) to receive 7-day transdermal buprenorphine patches (5, 10, and 20 µg/hour) or sublingual buprenorphine (200-mg and 400-mg tablets). Both medications were titrated to pain control (over a 21-day period) and patients were treated for up to 7 weeks. The primary outcome measure of this study was pain intensity (as measured by Box Scale-11 [BS-11], where 0=no pain; 10=pain as bad as you can imagine) at day 28.
During the 28-day assessment period, the mean treatment differences in BS-11 scores were 0.00 (95% CI, –0.68 to 0.69), –0.11 (95% CI, –0.85 to 0.63), and –0.13 (95% CI, –0.95 to 0.68), for the morning, midday, and evening scores. All the confidence intervals were within the pre-specified limits (–1.5 to 1.5) suggesting equivalent pain control with buprenorphine patches and sublingual tablets. The use of escape medication was low.
In addition to equivalent efficacy, transdermal buprenorphine was found to have superior tolerability in this randomized trial. Significantly fewer patients receiving the transdermal buprenorphine patches reported nausea, dizziness and vomiting compared with the sublingual formulation (P<.039 for all).
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
Read More
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
Listen
FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Read More