Background: In phase 3 trials, delayed-release dimethyl fumarate (DMF; also known as gastroresistant DMF) demonstrated efficacy in relapsing-remitting multiple sclerosis (MS). Gastrointestinal (GI) events were associated with DMF treatment. The single-arm, open-label MANAGE study examined the incidence, severity, duration, and management of GI events in adults with relapsing MS initiating DMF treatment in clinical practice in the United States shortly after marketing approval.
View Article and Find Full Text PDFBackground: The heated lidocaine/tetracaine patch (Synera; ZARS Pharma, Inc, Salt Lake City, UT) is among the local topical anesthetic formulations used to prevent procedural pain. This study was conducted to determine the depth and duration of anesthesia provided by the patch and to evaluate safety and tolerability.
Methods: This randomized, double-blind, placebo-controlled, 2-period crossover study was conducted in healthy subjects.
Objective: To evaluate the long-term safety, tolerability, and effectiveness of oxymorphone extended release (ER) in patients with cancer-related pain.
Design: Post hoc analysis of two-1-year open-label extension studies.
Setting: Multiple US cancer treatment facilities.
Objective: Assess the effectiveness and tolerability of a program of gradual dose titration with oxymorphone extended release (ER) for treatment of moderate to severe chronic pain in opioid-naive patients.
Design: Open-label, nonrandomized 6-month study with a titration/stabilization period of
Setting: Multidisciplinary pain centers in the United States.
Background: Patients are typically switched from parenteral opioids to oral opioids during the 24 to 48 hours after surgery. In June 2006, an oral immediate-release (IR) tablet formulation of oxymorphone was approved for the treatment of acute moderate to severe pain. Single doses of oxymorphone IR have been reported to provide significant pain relief after orthopedic surgery.
View Article and Find Full Text PDFObjective: Determine the efficacy and tolerability of oxymorphone extended release (OPANA ER) in opioid-naive patients with moderate to severe chronic low back pain (CLBP).
Design And Methods: Patients > or = 18 years of age were titrated with oxymorphone ER (5- to 10-mg increments every 12 h, every 3-7 days) to a well-tolerated, stabilized dose. Patients were then randomized to continue their oxymorphone ER dose or receive placebo every 12 h for 12 weeks.
Unlabelled: Opioid-experienced (N = 250) patients with chronic, moderate to severe low back pain (LBP) were converted from their prestudy opioid(s) to an approximately equianalgesic dose of OPANA ER (oxymorphone extended release). Patients continued slow titration, with 56% stabilized within 1 month to a dose of OPANA ER that reduced average pain to <40 mm on a visual analog scale with good tolerability. Stabilized patients (n = 143) were randomized to placebo or their stabilized dose of OPANA ER every 12 hours for a 12-week double-blind period.
View Article and Find Full Text PDFObjective: To assess the analgesic efficacy and safety of 5 mg of oxymorphone immediate release (IR) for mild to moderate pain.
Design: Multicenter, double-blind, randomized, placebo-controlled study.
Setting: Ambulatory surgical centers.
While many pre-clinical and clinical studies have suggested that the addition of N-methyl-D-aspartate (NMDA) receptor antagonists, such as dextromethorphan (DM), to opioid analgesics, such as morphine (MS), may enhance the analgesic effects and prevent the tolerance that may result from chronic opioid administration, others have not. The potential for reduced doses, enhanced opioid analgesia, and decreased analgesic tolerance associated with the MS/DM combination were evaluated in a series of three large, randomized, double-blind, parallel group, phase 3, multicenter trials each of 3 months duration in patients with chronic, non-malignant, non-neuropathic pain. To evaluate these unique endpoints, novel study designs were employed.
View Article and Find Full Text PDFPatients with moderate or severe pain following knee arthroplasty and washout from standard patient-controlled analgesia (PCA) were randomized to receive 20 mg of an extended-release (ER) oxymorphone formulation (n = 65) or placebo (n = 61) q12h for 1 day. Oxymorphone PCA was used as rescue analgesic. Oxymorphone ER provided significant improvements over placebo for most standard single-dose analgesic parameters, including mean total pain relief (TOTPAR) over 0 to 12 hours (19.
View Article and Find Full Text PDFJ Clin Pharmacol
March 2003
This randomized, controlled trial compared the analgesic efficacy and safety of the new oxycodone 10-mg/acetaminophen 325-mg formulation (Percocet) for the treatment of acute pain following oral surgery with double the dose of oxycodone alone (controlled-release [CR] oxycodone 20 mg [OxyContin]). A total of 150 male and female patients with > or = 2 full or partial bone-impacted mandibular molars, at least moderate persistent pain, and moderate trauma received a single dose of combination agent, CR oxycodone, or placebo following oral surgery and rated pain intensity and pain relief over the next 6 hours. The intent-to-treat population comprised 141 patients (55 on combination agent, 56 on oxycodone, and 30 on placebo).
View Article and Find Full Text PDFBackground: Several controlled clinical trials have demonstrated the efficacy and safety of the lidocaine patch 5% (LP) for the treatment of postherpetic neuralgia (PHN).
Objective: To assess the effects of the LP on distinct neuropathic pain qualities common to all neuropathic pain conditions, the authors analyzed data from one of the vehicle-controlled trials in which the Neuropathic Pain Scale (NPS), the only assessment tool specifically designed to measure the distinct components of neuropathic pain, was administered.
Methods And Results: To improve the sensitivity of the NPS to treatment effects, only patients who, at the time of enrollment in the study, reported moderate-to-severe pain on the NPS (as defined by a score > or =4/10 reported for at least 6 of the 10 individual NPS items) were included in the analysis.