Morphine Sulfate and Naltrexone Hydrochloride Extended Release Capsules in Patients with Chronic Osteoarthritis Pain

Abstract

MS-sNT provided effective analgesia in patients with chronic, moderate-to-severe osteoarthritis pain, with a safety profile typical of morphine-containing products. Naltrexone sequestered in MS-sNT had no clinically relevant effect when MS-sNT was taken as directed.

A multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of single-entity, once-daily hydrocodone tablets in patients with uncontrolled moderate to severe chronic low back pain

“…At week 12 of the double-blind period, the difference in pain scores between treatment groups was statistically significant (--0.53, p = 0.0016). This treatment difference was similar to the treatment differences observed with other extendedrelease mu opioid analgesics in studies of similar design, such as hydrocodone [48], morphine [49], and oxycodone [50]. The robustness of the primary analysis results was supported by four sensitivity analyses that used different approaches for handling missing data (p < 0.01, differences ranged from p = 0.55 to 0.67), two responder analyses (p = 0.0033 and 0.0225), and an analysis of PGIC (p = 0.0036).…”

Systematic review of enriched enrolment, randomised withdrawal trial designs in chronic pain

“…22 Three long-duration trials without high risk of bias were also positive: pregabalin in fibromyalgia, 13 hydromorphone in chronic low back pain, 23 and morphine/naltrexone in osteoarthritis. 30 The negative results were not unexpected, for opioids in chronic low back pain, 78 for glucosamine in well-established osteoarthritis, 10 and perhaps for pregabalin in chronic lumbosacral radiculopathy. 4 A negative result for lidocaine plaster in postherpetic neuralgia 5 is difficult to judge because evidence from classic trials is weak.…”

Long-Term Treatment of Osteoarthritis Pain: Achieving a Balance Between Efficacy and Tolerability for a Successful Chronic Therapy

“…Improvements in WOMAC scores have been observed in studies of fentanyl, oxycodone, oxycodone/acetaminophen, morphine sulfate, oxymorphone, and hydromorphone for osteoarthritis pain (Caldwell et al, 2002;Hale et al, 2007;Katz et al, 2010;Langford et al, 2006;Matsumoto et al, 2005). In addition, improvements in sleep, mood, and enjoyment of life have been associated with opioid analgesic therapy for the management of chronic osteoarthritis pain (Rosenthal et al, 2007;Roth et al, 2000).…”